241 Ich Jobs - Page 4

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best practices to stakeholders. Job Requirements Strong understanding of risk management principles and practices. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills, with the ability to build relationships with stakeholders. Experience working with financial data and systems, including risk management software. Strong knowledge of regulatory requirements and industry standards related to risk management.

We are looking for a highly skilled and experienced Relationship Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in the BFSI industry, preferably with a background in Mutual Funds Collections. Roles and Responsibility Manage and maintain strong relationships with clients to ensure timely payments and minimize defaults. Develop and implement effective strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues promptly. Analyze market trends and competitor activity to identify opportunities for growth and improvement. Provide excellent customer service to build trust and loyalty with clients. Identify and mitigate potential risks associated with mutual fund investments. Job Requirements Strong knowledge of financial products and services, particularly mutual funds. Excellent communication and interpersonal skills to build strong client relationships. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills to analyze data and make informed decisions. Experience working with collections and recovery teams is an asset. Familiarity with regulatory requirements and compliance standards is desirable.

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues related to payments. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions with customers. Job Requirements Strong knowledge of banking regulations and laws. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Proficient in Microsoft Office and other software applications. Strong analytical and problem-solving skills. Ability to maintain confidentiality and handle sensitive information. Experience working in a similar role within the BFSI industry is preferred. Location: Chennai,Gingee,Vellore,Viluppuram

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job description Bangalore, India Job category Clinical Development Department Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Key Responsibilities in this position will be to perform a Medical Review of all trial subjects of all assigned clinical trials within the drug development portfolio across therapy areas & to ensure high-quality quality consistent medical data. Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs). Senior Medical Reviewer ensures high-quality medical data through medical review of clinical trial data. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialists during trial conduct. Report the status of the medical review to the project as appropriate, following the project communication plan and blinding plan. Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications Minimum as Graduate in Medicine or other relevant (MBBS & MD in pharmacology preferred, MBBS & MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research). 2-3 years of experience as a Medical Reviewer is preferred. 1-2 years of experience in project management is required. Good knowledge of ICH (International Council for Harmonisation of Technical for Pharmaceuticals for Human Use), and GCP (Good Clinical Practice). Demonstrated computer skills (MS Office, MS Project, PowerPoint). Excellent understanding of medical terminology and clinical trial activities. Strong Analytical skills and result-oriented. Excellent written and spoken English. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we re working toward something bigger than ourselves, and it s a collective effort. Join us! Together, we go further. Together, we re life-changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). 10th May 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we re life changing. Print job Send to e-mail Related jobs

Job Title: Senior Statistical Programmer II Career Level: D Introduction to role: Are you ready to make a significant impact in the world of rare disease biopharma? As a Senior Statistical Programmer II, youll be at the forefront of developing and validating programs that create datasets conforming to Alexion and CDISC standards. You will play a pivotal role in generating Tables, Listings, and Figures for analysis purposes. Depending on the complexity of the study, you may lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Your expertise will guide and mentor junior programmers, while your ability to integrate statistical concepts with SAS Programming will drive efficiency and effectiveness. Are you prepared to take on this challenge? Accountabilities: Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM, and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems. Clearly communicate processes and standards with management and team members. High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, youll find yourself immersed in a culture that thrives on innovation and collaboration. Our commitment to transforming complex biology into transformative medicines is unwavering. With a rapidly expanding portfolio in rare disease biopharma, youll have the chance to grow and innovate alongside exceptional leaders and peers. Our entrepreneurial spirit fosters autonomy and connection, empowering you to explore new ideas while meeting the needs of under-served patients worldwide. Here, your career is not just a path but a journey to making a difference where it truly counts. Ready to embark on this exciting journey with us? Apply now to join our team! 04-Jun-2025 04-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com . Alexion participates in E-Verify.

Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role Definition: Manage product regulatory compliance risks (non-emission) and ensure compliance for all Caterpillar and allied products / business and enable market access in India region*. (*) India regionIndia, Sri Lanka, Nepal, Bhutan and Bangladesh Responsibilities Actively engage / proactively work with pertinent Standards Development Organizations ( SDO) such as Bureau of Indian Standards(BIS), Indian Road Congress(IRC), Regulators, and Trade Associations (TA) to drive advocacy / draft requirements for Construction Earthmoving , Material Handling and Mining (CEMM) Industry. Identify / Stay abreast on current and upcoming India region product regulatory requirements. Assess implications of upcoming regulations on Caterpillar products, solutions, and services. Collaborate with Government affairs team, TA s and Ministry to mitigate potential compliance challenges Work with all related teams to ensure that all Caterpillar products, solutions, and services are compliant after effective date. Be part of NPI teams to proactively guide / ensure all products placed in India region market meets regulatory requirements Develop guidance documents to guide all internal teams on regulatory requirements. Periodically update all stakeholders on regulatory developments. Identify continuous improvement opportunities for processes and tools used to manage product regulatory compliance risks. Degree Requirement B.E/ B.Tech from an accredited institution is mandatory with 12+ years of relevant experience in Engineering, Marketing or other areas in the organization is preferred. Skill & Competency Descriptors Technical knowledge Deep Product and process knowledge: Level Extensive experience Working knowledge of CAT Products, Product application / usage, services & solutions provided in India region Good working experience of CAT processes (NPI, Trade, Certification) Strong communication skills - Verbal and written Experience of working with several product groups a plus Collaborating skillsAbility to work with all stakeholders in a constructive and collaborative manner. Level Working Knowledge: Demonstrates experience participating in productive collaborative processes. Initiates collaborative meetings with all pertinent stakeholders. Communicates plan / actions to manage compliance risks Supports to promote collaboration across functions, businesses, and levels. Helps solve business problems and meet business goals through collaborative processes. Risk ManagementKnowledge of processes, tools and techniques for assessing and controlling an organization's exposure to risks of various kinds; Ability to apply knowledge of risk management appropriately to diverse situations. Level Working Knowledge Proactively identifies compliance risks (non-emissions) for all Caterpillar businesses in India Leverages risk assessment models and techniques to assess compliance risks. Leverages Produces and interprets common risk assessment and management reports. Implements or manages risk management for own area. Documents the key steps of risk management and associated procedures. Product Development Knowledge of product development process and leverages knowledge to ensure compliance aspects are embedded as part of product development. Level Working Knowledge Reviews and assesses proposed solutions to mitigate compliance risks. Creates, disseminates, and maintains best practice documentation. Monitors the use and feasibility of best practices within a product development department on compliance matters Highlight any issues related to major resources and logistics for applying best practices. Willing to travel Approx. 30% Relocation is available for this position. Posting Dates: May 29, 2025 - June 5, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community .

: Job Title - Non Party Reference Data, NCT Location - Bangalore, India Role Description: The Senior Analyst will be responsible for completion of day-to-day activity for IRDS process. The primary function of the role is to work within Reference Data Space which includes Reference/static data setup and maintenance, Data quality queries/ issues received from client, Exception management, Reconciliation of data between systems, monitoring the data quality report and to ensure accurate, timely and quality delivery of services provided within a risk-free controlled environment, to ensure Deutsche Banks overall client satisfaction. Further daily/weekly/Monthly MIS, client escalation, other reports and ad-hoc work would also be handled What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Should have a very good knowledge of Reference Data Services (Financial Instruments) To work on all the assigned tasks and ensure the delivery is done as per KPI. Should have SQL Knowledge (advantage). To act as an SME of the process. To be able to train the new Joiner as and when required. Own and maintain KOP of the respective process. Ensure completion / adherence of activity as per standard procedure/key operating procedure. Ensure quality/quantity of processing is maintained as per the SLA. Ensure Daily/Weekly/Monthly MIS is published. To handle escalations from client or escalate issues in time, to the TM level, to avoid any adverse impact on the business. Ensure teamwork culture is practiced. Ensure proper back-ups created and assist other teams during contingencies (Staff shortage, high volumes etc.,) Your skills and experience Skills Needs to be a self-starter with significant ability to undertake initiatives. Strong interpersonal / good negotiations skills are required, Follow through skills, Effective communication skills, Ability to confidently handle internal clients and open for shifts (APAC/EMEA/NY Education/ Qualification Graduates with good academic records Experience of 4-7 years with functional RDS background Having technical (SQL basic) would be an added advantage. Proven problem-solving skills. How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

: In Scope of Position based Promotions (INTERNAL only) Job Title Auditor Associate Location Bangalore, India Role Description The Audit Analyst/Auditor will be initially working with the various teams supporting the coverage of Indian and other APAC legal entities and processes. After the initial training and development phase, the Audit Analyst/Auditor will eventually join one of the global audit teams on a permanent basis. Timing of the permanent assignment will vary depending on personal development, experience and opportunities available. During the initial assignment, the Audit Analyst/Auditor will be exposed various audit processes covering key divisional and infrastructure units. In addition, the Audit Analyst/Auditor will also support ad hoc RBI requests where appropriate. In addition to conducting audit work across these functions, the team also works closely with other audit teams (e.g. Technology) to provide integrated coverage and assurance. The Audit Analyst/Auditor works on supervised audit activities and undertakes audit work of a specific business/function area in accordance with the audit methodology and evaluates the adequacy and effectiveness of internal controls. The Audit Analyst/Auditor works in a cooperative manner with subject matter experts and other teams from across the function to provide front-to-back audit coverage. The Audit Analyst/Auditor will use a range of approaches to collect relevant and readily available information to assess risk, resolve issues or carry out tasks. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Auditor: Auditors work independently on audits and/or on tasks delegated to them within the scope for audits for a specific business/functional area/region and may sometimes work on multiple audits at the same time. Auditors evaluate the adequacy and effectiveness of internal controls relating to the risks within those business areas, working under moderate supervision, e.g. in complex situations. Auditors proactively develop and maintain professional consultative working relationships within their own function and with stakeholders inside the bank and respective support areas. They will use a range of approaches to collect relevant information to assess key risks, resolve issues or carry out tasks. Auditors work in a co-operative manner with subject matter experts and other teams from across the function and outside the function to provide front-to-back audit coverage. Auditors may occasionally participate in ad-hoc projects. Audit Analyst: The Audit Analyst supports on audits of a specific business/functional area/region, with specific guidance. They predominantly support the audit team on analytical aspects of audit work throughout the entire audit lifecycle. The Audit Analyst will focus on the fieldwork phase of an audit and building a working knowledge of the audit methodology. Assists on audit assignments and undertakes work in accordance with the Audit methodology within agreed budgets and timelines, including documenting Activity Flows, identification of key risks, testing of key controls to evaluate the adequacy and effectiveness and documenting work in accordance with divisional standards. Proactively keeps abreast of pertinent industry, regulatory and business practices. Proactively develops and maintains professional consultative working relationships, primarily within the audit team. Takes ownership for own development and career management, seeking opportunities for continuous development of knowledge and personal capability and improved performance contribution and acts as a role model within their own team. Your skills and experience The candidate must have: Bachelor Degree (or equivalent) from an accredited college or university (or equivalent); including some knowledge of auditing standards and concepts. Awareness of general banking environment and/or awareness of the risks and regulatory requirements. Fluent in English, communicating with clarity, both verbally and in writing, in a logical order and structured approach. Dedication on self-development and building technical knowledge. Advanced knowledge of Microsoft Excel, Word and Power Point. Critical thinker with understanding of emerging technologies (Cloud, AI, Python etc.) Good analytical, problem solving, relationship management and presentation skills. Ability to work in virtual, global teams in a matrix organisation. Self-starter with the ability to multi-task assignments, prioritize workload and be resilient under pressure when faced with tight deadlines and in a fast-paced business environment The ability to challenge and be challenged whilst maintaining the highest levels of professionalism. Unquestionable personal integrity and ethics. How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs.

Develop and maintain effective regulatory writing processes and practices. Supports the safety and compliance function (SCR) in performing the required activities that ensure compliance with domestic and international regulatory agency requirements and standards, in line with customer requests. Work with suppliers and stake holders to get required evidence as per the compliance requirement. Support requests for testing from country and/or regulatory agencies. Support teams in preparing product technical reports and Safety risk assessment reports. Support Material compliance requirement from markets: EU REACH, ROHS, Prop 65, SCIP & other regulatory requirements.

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities. Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude. Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Good Communication Skills Roles and Responsibilities: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities. Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude. Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft WordBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Good Communication Skills Roles and Responsibilities: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities. Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) Operations Roles and Responsibilities: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Required Skills: Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Good Communication Skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Good Communication Skills In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) Operations In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Contract Management - Contract management Designation: Contracting Counsel Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Legal Buyside Contracting Role Summary – To provide comprehensive legal support to Procurement and Business teams which includes drafting, reviewing, negotiation and execution of contracts, NDA's and other documents relevant to procurement support in accordance with company policies and procedures, applicable laws and customer requirements. Provide advisory support to procurement and business teams by driving the creation of templates, standardize the templates, maintain and continuously improve the standard contracts templates and procedures for complex buyside deals in accordance with changing laws and company policies. Develop specialized subject-matter expertise in support area to seamlessly address any potential risks or issues.Complexity: Requires identifying and assessing complex problems for area of responsibility. Creates solutions in situations in which analysis requires an in-depth evaluation of variable factors. Requires adherence to strategic direction set by senior management when establishing near-term goals. Interaction is with senior management of the team, internal stakeholders third party vendors, contractors subcontractors etc., involving matters that may require acceptance of an alternate approach..Authority:Some latitude in decision-making. Acts independently to determine methods and procedures on new assignments.Impact or Decision Impact:Decisions have a major day to day impact on area of responsibility.Scope:Manages large - medium sized teams and/or work efforts (if in an individual contributor role).Relationships:Supervises:?Team members providing services on a process/project or account/portfolio of accountsExternal Relationships:?Procurement, Business Executives, Contract Management, Outside counsels, Vendors, Corporate Function related stakeholders like HR, Workplace etc. What are we looking for? Bachelor's degree in LawCertifications and Membership:?Contract related global professional certification considered a plusWork Experience:?Minimum of 5 to 15 years of experience at law firm or as in-house counsel and/or in legal outsourcingKnowledge and Skill Requirements: Expert level understanding of both commercial and legal contractual risks and displays ability to provide business-oriented legal advice Fluent in English with strong oral and written skills Experience in managing end-to-end projects and teams on function specific processes and/or areas, work with internal and external teams, and understands delivery requirements Demonstrate excellent interpersonal skills, is detail-oriented, has sound judgement, is adaptable, demonstrate promptness, accuracy, and consistency with the activities supported, and drive tasks to closure, has strong time management, prioritization, organizational skills Build trust-based relationships by delivering on commitments, ability to work under pressure, with exposure to senior management Effectively manage priorities and stakeholder expectations Able to effectively influence senior management. Good understanding of Accenture offerings and function specific services performed, very good understanding of commercial agreements, legal and compliance fundamentals, corporate business practices, and contracting regulations Comfortable with technology and has experience in the use of tools & databasesBehaviours and Attributes: Open to work with and understand cross-cultures and locations throughout Accenture global organization Understand the value of diversity and recognize the strengths that different styles, innovative perspectives and experiences bring to Accenture Demonstrate inclusion and respect for all individuals regardless of gender, race, ethnicity, religion, belief, age, disability, culture, social status and/or sexuality Leader as well as team player, collaborative and persuasive; able to work well with executives and non-executives.Work Requirements:?Travel may be required Fluency in English (and other language, depending on geography supported) with very strong oral and written communication skills. Roles and Responsibilities: Generic Responsibilities Qualifications Any Graduation

Dossier Power House

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills

Division Integrated Product Development Department R&D Formulations Sub Department 1 Formulation ADL Job Purpose Execute the core method development activities and conduct analysis of routine as well as stability samples to finalize specifications and ensure timely delivery of product to unit. Key Accountabilities (1/6) Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Provide support to units or CFTs for transfer of analytical methods and techniques by visiting and demonstrating them with the relevant analysis to ensure successful and timely transfer of products Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations Key Accountabilities (2/6) Key Accountabilities (3/6) Key Accountabilities (4/6) Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Key Interactions (1/2) Key Interactions (2/2) Dimensions (1/2) Dimensions (2/2) Key Decisions (1/2) Key Decisions (2/2) Education Qualification M. Sc. (Analytical Chemistry) / M. Pharm Relevant Work Experience 2-4 years of experience in pharmaceutical organisation with knowledge of handling instruments like HPLC, GC, Dissolution tester and DPI related instruments Knowledge of current guidelines like ICH, EMEA, WHO

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills

* Deviation Management * Quality System Implementation * Regulatory Compliance * Process Validation * Documentations & Audits

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and obtain approvals from CDSCO i.e., FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e., Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN, i.e., Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R&D, Quality Unit, Manufacturing, Supply Chain and Marketing team. Work closely with R&D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. Well versed about the online portals i.e., Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. He/She should be able to handle the queries raised by the aforesaid government department. Need to possess good communication.