53 Regulatory Guidelines Jobs - Page 2

Role & responsibilities Position: Regulatory Associate CMC Location: Remote (India) Were looking for passionate professionals ready to grow their careers in a dynamic, global organization. Role Requirements: Masters degree in Pharmaceutical Sciences Minimum 2 years of experience in regulatory, quality, or document management support Hands-on experience with CMC (pre- and post-approval) Familiarity with Module 1 document preparation and country-specific administrative forms Skilled in maintaining regulatory trackers, submission timelines, and status reports Strong interpersonal and communication abilities Proficient in Microsoft Office (Word, Excel, PowerPoint) Be a part of meaningful work that impacts patients' lives around the world. QUALIFICATION REQUIREMENTS Masters in pharmaceutical sciences. Minimum around 2 years of experience in a regulatory, quality, or document management support role. Excellent interpersonal / communication skills. Advanced skills in Microsoft Office Applications. Good time and project management skills, preferred. Strong analytical skills and attention to detail. Ability to work both as a team member and independently and to understand and carry out detailed instructions. Ability to interact with staff from multiple departments. Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

Role & responsibilities: The candidates Core Profile would be Handling RBI Compliances, so 3-5 years RBI Experience is must. Required Experience: RBI Ensuring various Compliances under Master Direction of Reserve Bank of India for NBFCs and amended Rules thereon. Dealing with various circulars as issued by RBI i.e. Scale Based Regulations, Outsourcing Guidelines etc. Dealing with Fraud Guidelines and filing returns of fraud i.e. Monthly Certificate of Fraud, FMR-1, FMR-3 & FMR-4 (XBRL / CIMS Format) Taking prior approval from RBI for appointment of Directors & other matters Handling Select scope inspection from RBI and drafting of requisite replies for the inspection letter Working Knowledge of Inspection of RBI Preparation & filing of various monthly, quarterly, half yearly & annually returns of RBI i.e. Returns of Short-Term Foreign Currency Borrowing, quarterly overseas borrowing return, Statement of Change of Directors & Auditor Report etc. LEI obtaining and yearly renewal. Filing Return of Digital Lending Apps (DLA Return) Filing of Entity Master Data through Single Master Form (SMF-FIRMS) with the RBI. Filing of application for registration of a Company as NBFC with the Reserve Bank of India. Preference for additional experience: Companies Act & SEBI Compliances Compliance of relevant provisions of the SEBI Listing Regulations including LODR, Insider Trading, SAST, ICDR. Ensuring various listing compliances of Equity & Debt i.e. monthly, quarterly, half yearly, annually, event based etc. Listing of Non-Convertible Debentures (NCD) Handling Related Party Transactions (RPTs), Corporate Social Responsibility (CSR) Compliances Preparation of Notice, Agenda and Minutes of Meetings of Board and Committees. Assistance in Convening Board Meetings and General Meetings of the Company. Maintaining the Statutory Register and Records. Compliance of various applicable provisions of Companies Act, 2013 on a Public Limited Company ESOP Policy Drafting & ESOP Compliances. Drafting of various policies of the Company. Preparation of Annual Return, Board Report and Annual Report of the Company. Filing of various E-Forms with the Registrar of Companies (ROC). Filing of return of FLA, FCGPR, FCTRS and various other returns under FEMA Regulations Liaison & Co-ordination Liaison with Government Officials of Ministry of Corporate Affairs, Registrar of Companies, Stock Exchanges, Depositories & RBI Liaison with Counsels, RTAs wrt Share related matters.

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Role & responsibilities The role of Wholesale Banking - Business Unit Compliance Officer (WB BUCO)” is to reinforce the compliance culture in Wholesale Banking and proactively addressing regulatory and operational risk minimizing losses and providing operational stability. It encompasses implementation of regulatory guidelines within all Wholesale Banking Business and Product units, viz. Large Corporates, Mid-Corporates, Financial Institutions, Government Institutions, Multinational Corporates, Transaction Banking, Project Finance, and Loan Syndication, working in close coordination with Central Compliance and Operational Risk Management units” Strengthens Compliance Culture - Reinforces the Banks “Zero Tolerance” to compliance and operational risks. Mitigates Risks - Helps identify assess and address compliance risks proactively. Ensures Business Stability - Protects the Bank from legal, financial and reputational harm. Effective management of Operational risk - Enhances monitoring and accountability within each unit in Wholesale Banking by proactive identification, assessment and mitigation of risks arising from internal and external events. Preferred candidate profile

Role & responsibilities 1. Formulation & Development for emerging & regulated market. 2. Execution of Lab Trial batches & Tech Transfer activities at site. 3. Lab note book writing & documentation ensuring compliance with regulatory guidelines \ Preferred candidate profile - Experience in Tablets, Capsule, Pellets, ER, SR, and DR product development for emerging market.

This Opportunity is with a leading Banking company for their office in Mumbai location Role: MIS & Regulatory Submissions - TM Experience: 10 - 15 Years Job Description: PURPOSE OF THE JOB: - Will be responsible for reporting of Complaints Performance which includes Closure TAT, Pendency and Top Areas of Complaints, different MIS on complaints to senior management and all regulatory submissions. As a control function, will be responsible to identify non-compliance to Complaint Management processes of the bank, incorrect selection of CRM fields, and to ensure corrective action/ process improvement. Roles & Responsibilities: KEY RESPONSIBILITIES: 6 - 8 Areas Actionable (4-6) Regulatory Reporting Will be responsible for preparation of quarterly submissions to Standing Committee and Customer Service Committee of the Board, Annual disclosure of complaints to publish in Banks annual report Will be responsible for other regulatory submissions like yearly Bank Profile, RBI Tranche I, II and III submissions, sustainability report etc. within the agreed timelines Will be responsible to ensure submissions on complaints in compliance to RBI Master circular Will be responsible to ensure compliance to RBI Master Direction on Internal Ombudsman dated 29th Dec2023 Periodical Reports to Senior Management on complaints Will be responsible for preparation of various MIS on Complaints Performance, closure TAT, pendency and Top Areas of Complaints to Senior management for review and inputs. Will be responsible for preparation of monthly reports on complaints and daily, weekly and monthly dashboards on TAT performance to all Business Heads and Group Heads Will be responsible for preparation quarterly reports to ICAAP team and any adhoc MIS required by senior management. CRM Analysis Will be responsible for assessment on quality of CRM logged and closed, share feedback to the assesses to ensure improvement in these parameters. Complaint Management Note Will be responsible for quarterly review of Complaint Management Note and update changes wherever required. Control Function Will be responsible to identify non-compliance to Complaint Management processes of the bank, incorrect selection of CRM fields etc and to ensure corrective action/ improvement in the area by highlighting the same to senior management and guiding the correct process Audit and Compliance All the requirements raised by RBI Audit, Internal Audit and Statutory Audit are submitted in a timely manner Compliance of all Audit observations and closure on time Review of Complaint Management processes/notes and ensure compliance of the same Supervisory Role Will ensure training to new joinees. Will be ensuring regular feedback, guidance to the team and performance appraisal for the team Educational Qualifications - Graduation Key Skills: Graduation MS office proficiency Analytical skills Banking Product & Process Knowledge Communication Skills Experience Required: Minimum experience in years' 10 yrs Exposure to banking preferable Interested Candidates can share their CV's at priyal@topgearconsultants.com

Hands-on experience in designing, launching, & managing Prepaid Forex Card programs. shaping & executing our prepaid product strategy, ensuring seamless operations, regulatory compliance, and delivering value to our customers Required Candidate profile Understanding & internalising the cost and revenue aspects of the card program as given by Network partners. Negotiation with Program managers on various aspects of card launch

Job description -Candidate should possess experience in carrying out audit in Treasury function covering Derivatives, Forex dealing room. The activities to be covered as part of the audit would inter-alia cover the following aspects: Document verification of Forex and derivative transactions Term Sheet scrutiny along with detailed scenario analysis Review of entries related to forex and treasury operations on sample basis Settlement checks Voice Record checks Experience in handling concurrent audits / internal audits in the areas of Treasury function. Candidate should possess experience in carrying out audit in Treasury function covering Fixed Income Securities, Equities, Forex etc. Candidate should be well versed/updated in Regulatory guidelines in Treasury domain. To conduct concurrent audit of the areas assigned, discuss the audit observations with auditee and prepare the audit report. Good knowledge on Treasury products To assist in preparation of Board / Audit Committee notes pertaining to Treasury. To assist in checking compliance in various treasury processes as required by SOX. To constantly identify key risk areas in treasury function, recommend and implement change process. To carry out UAT reviews for treasury related systems and conduct special audits in the areas of Treasury, risk and allied areas

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.

Knowledge of Process development for APIs and intermediates/Trouble shooting of products at plant level/Planning and executing the experiments/Technology transfer to plant level/Handling reactions from mg to gram scale/ API R&D Required Candidate profile Cost reduction and plant troubleshooting/OD at plant site for technology transfer as & when required/ Chemistry/Regulatory Guidelines/GMP/GLP/ Timely delivery/ Compound interpretation NMR/LCMS/HPLC

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

Ensure compliance with corporate laws, including Companies Act, SEBI regulations, and FEMA guidelines. Organize board and committee meetings, including scheduling maintain statutory records and filings with regulatory bodies such as MCA, SEBI, RBI

Role & responsibilities: Conduct IS audits across technology domains; ITGC Controls, Risk Assessment, VA/PT, Application Security, NSAR, CA Assist in implementing a risk-based audit plan aligned with the organisation's audit objectives. Ensure timely completion of audit assignments and maintain clear, accurate documentation. Provide insights and recommendations to enhance internal systems, controls and policies. Update and maintain Audit Procedure Manuals and audit checklists. Collaborate with cross-functional teams to ensure regulatory and compliance alignment. Follow departmental risk policies and protocols to mitigate operational, financial, regulatory and reputational risks. Execute internal control mechanisms effectively and support audit processes by providing necessary information. Demonstrate strong presentation skills and thorough understanding of regulatory compliance requirements. Preferred candidate profile Experienced in ITGC Controls, Risk Assessment, VA/PT, Application Security, NSAR, CA Has ISO Certifications Proficient in Business Continuity Planning/Disaster Recover and Change/Incident Management Knowledge of Cybersecurity & Cloud Security, Security Operations and Surveillance Strong knowledge of regulatory circulars and guidelines. Banking domain experience preffered

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products

Job title: Principal Data Management Programmer Location: Hyderabad, India About The Job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives ReadyAs Principal Data Management Programmer within our Hyderabad Hub, youll be responsible for developing program for data validation, data review and protocol deviation deliverables for assigned projects, providing timely support to Study Team(s) on data management programming or data visualization analytics according to project data cleaning strategies through project milestones from study start-up to database lock, We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible Ready to get started Main Responsibilities Developing listings, summary tables, figures and/or advanced analytics for data validation, data review, medical review, AE dedicated review and SAE reconciliation Distributing and/or deploying data review and data validation solutions which are checking all collected data including external data (i-e, cross-panel checks and internal/external data reconciliation) Developing automatic protocol deviations identification solutions Liaising with standard Data Reporting Analyst (DRA) to continuously maintain and optimize the existing standard reporting tools, programs and report library, Developing efficient Power BI, Spotfire, R/Shiny & SAS standard packages facilitating the programming of study solutions Managing the technical writing at CTT level (i-e, user guides, detailed specifications, best practices, programming conventions, etc ) Analyzing new requirements from customer and propose technical solution strategies, About You Experience: Strong SAS programming experience or have other equivalent programming language experience such as R/R shiny, Python, or have equivalent data visualization tools experience such as Spotfire, Power BI, Tableau In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred, Soft and technical skills: Advanced project management skill Advanced collaboration and communication skill Outstanding capability of independent thinking and delivery of accurate outcomes Meeting management skill such as organize meeting and discussion Crystal clear logical thinking Good coaching and people development skill Intercultural skills with ability to work effectively in a multi-cultural context, Expertise in programming language such as SAS, R, Python Expertise in database structure and data flow Knowledge of industry standards and practices (e-g CDISC especially CDASH and SDTM) Knowledge of data visualization tools such as Spotfire, Power BI, Tableau Experience in implementing and fine-tuning AI/ML model Strong knowledge of current regulatory guidelines, and GCP practices regarding Data Management Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Education: Bachelor or Master of Science degree or above, preferably in a life science or mathematics-related area (e-g , Pharmaceutical, medical, or mathematics, computer science or similar technical fields), Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment, Why choose us Bring the miracles of science to life alongside a supportive, future-focused team, Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally, Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact, Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeksgender-neutral parental leave, Join an international innovative biopharma company, Lead data management programming activities and serve as an expert working on several therapeutic areas, Participate in the evolution of Clinical Data Management and deployment of innovations ?As a principal data management programmer in our India Hub, youll get the opportunity to lead data management programming for global studies in different therapeutic areas and act as the expert to develop your career in the global organization Join the Best, Be the Best!? null

work: Expert in regulatory compliance Oversee RBI reporting, guidelines adherence & risk management Manage government affairs, liaison & relations FEMA expertise Escrow & Consortium Knowledge Biz Development & Management Communication skills Annual bonus Health insurance

Role & responsibilities Should be well conversant with IRAC, Exposure, Large exposure norms, Resolution Plan Implementation, Sensitive sector monitoring, etc. Exposure in preparation of DSB, CRILC, PSL, MSME, SLBC, Defaulter, NPA, Bureau reporting (CIBIL), NeSL submission, Quarterly disclosure preparation, Risk Based Supervision submission, Potential NPA tracking, Exception reports, SCOD tracking, etc. Facilitate Half yearly review of all process notes and QC checklists to align with extant circulars. Excellent oral and written communication. Excellent project management skills to manage multiple automation projects with circular implementations. To be able to provide assistance in evaluation and Review of BRDs as well as facilitating UATs for automation projects. Ability to manage work with minimum supervision. Ability to drive all process improvement initiatives. Ability to work under pressure and manage stakeholders expectations. Exposure towards handling Regulatory/Statutory/Concurrent audits and track open audit points till closure.

About The Role : In Scope of Position based Promotions (INTERNAL only) Job Title Model Validation Specialist Associate Location Mumbai, India Role Description Model Risk Managements mission is to manage, independently and actively, model risk globally in line with the bank's risk appetite with responsibility for: Performing robust independent model validation; Ensuring early and proactive identification of Model Risks; Effectively managing and mitigating Model Risks; Establishing Model Risk metrics; Designing and implementing a strong Model Risk Management and governance framework; Supporting bank-wide Model Risk-related policies. This role spans all aspects of validation applicable to the portfolio of estimation approaches within the Deutsche Bank Combined US Operations (CUSO) across all relevant business units and risk types. 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 The core responsibility will be to validate IB Stress testing models used within the larger CCAR PPNR umbrella for DB USA. Its important for incumbent to grasp and understand Investment Banking side of the banks business. However, the role might necessitate model validator to be flexible in moving around different risk areas within US model validation team outside of core area of responsibility. Key tasks include, but not limited to model performance testing, scenario analysis, sensitivity analysis, and conceptual assessment of model assumptions/limitations/weaknesses. Developing challenger models including independent data collection and by performing complex analysis and testing. Follow regulatory guidelines and the Banks policies and procedures for model risk management, especially CCAR-specific guidelines. Bringing efficiency by automating processes and uplifting frameworks. Your skills and experience 3-6 years of professional experience in model development/ validation or related areas. Previous experience in stress testing (DFAST/CCAR/ICAAP) would be a plus. Ability to analyse and understand financial statements (Balance sheet, Income statement) will be advantageous. Candidate needs to have decent knowledge about financial products and the associated risk factors. Candidate needs to have above average report drafting skills and should be able to independently compile model validation reports, follow-through on mitigation of validation findings, and documentation thereof. Very strong data management and analysis skills with experience in relevant software packages, e.g., R and Python. Good presentation & communication skills Candidates with Mathematics/Statistics/Economics/Engineering/ MBA or allied background holding Graduate/Post-Graduate degrees are preferred. CFA / FRM certification will be a plus for the role. 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.

About The Role : Job TitleClient Implementation Analyst, NCT LocationPune, India Role Description In accordance with Anti-Money Laundering Requirements, Banks are obliged to perform Know-your-client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirement and the banks internal policies. The project involves verification of the Client data, performing due diligence checks on the Clients, reviewing KYC documentation performing the risk assessment of the Client, liaising with the Business/Compliance, advising on KYC requirements and signing off on new client adoptions. 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 Responsible for verification of Client data Perform due diligence of new and existing clients covering a wide range of different client types including; Listed and Regulated, small/medium/ large private and public companies as well as more complex structures such as; SPVs, Co-operatives, Foundations and Funds, Governments, Joint Ventures, etc. Verifying KYC documentation of the Clients to be adopted/reviewed Perform the risk assessment of the Client to be adopted/reviewed Signing off on new client adoptions and periodic reviews Manage New Client Adoption or Periodic Review stream, to ensure that all requests are approved in accordance with regulatory requirements and the banks internal policies Manage exception ensuring that all SLAs defined with the Business on timeliness and quality are adhered Your skills and experience Domain Skills 1 to 2 years of relevant work experience (AML/KYC/compliance related) within corporate financial services industry, Research/Analytics role in other Banks / KPOs etc Understanding of Control, Compliance, Investigation/chasing functions in banks Familiarity AML/KYC regulations and industry guidelines Ability to interpret regulatory guidelines and assessing risk scores and entity types Ability to interpreting alerts Ability to identifying trends and inconsistencies Understanding of end to end KYC process Communication and Reasoning skills Good German Language Skills Written & Verbal B2.2 level Good reading, comprehension and critical reasoning skills Good analytical writing skills Good communication skills to communicate at all levels - onshore & stakeholders Soft Skills Ability to work independently and take ownership Flexibility while handling multiple cases of varying priorities Graduates with good academic records Exposure to draft procedures based on policies formulated by the Bank's AML Compliance departments. Relevant KYC experience in any Financial Sector for a minimum of 2 years 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

Role & responsibilities Safety Officer to oversee and enforce safety protocols in our pharmaceutical manufacturing environment. The ideal candidate will ensure compliance with occupational health, safety, and environmental standards, contributing to a safe workplace and sustainable operations. This position requires strong working knowledge of pharmaceutical industry safety norms, including GMP and regulatory guidelines. Implement, monitor, and continuously improve safety systems in compliance with GMP , GSP , and regulatory guidelines (USFDA, MHRA, WHO, etc.). Conduct safety audits, risk assessments, and inspections within manufacturing, laboratory, and utility areas. Develop, implement, and regularly update Standard Operating Procedures (SOPs) for health and safety. Identify potential safety hazards and lead preventive and corrective action planning. Investigate incidents and near-misses; prepare detailed reports and suggest preventive strategies. Organize and conduct training programs on occupational health, fire safety, PPE usage, hazardous material handling , and emergency response. Ensure proper documentation of safety activities and compliance in line with QMS and GMP requirements. Liaise with internal departments and regulatory authorities during audits and inspections. Maintain records of MSDS, incident logs, training records, and statutory compliance. Monitor contractor safety during construction or maintenance activities within plant premises. Qualifications: Educational Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm / B.Tech Diploma in Industrial Safety from a DiSH-recognized institution Mandatory Experience: 3 to 6 years of experience in a similar role, preferably in a pharmaceutical manufacturing or API plant.

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

Job Responsibilities: Perform pre-formulation studies, R&D trials and support scale-up activities. Conduct R&D trials for oral solid dosage forms (tablets, capsules, etc.). Develop and optimize formulations to meet regulatory and quality requirements. Document and analyze trial data to improve formulations. Collaborate with cross-functional teams for technology transfer to manufacturing. Requirements: M.Pharm or equivalent in Pharmaceutics/Pharmaceutical Sciences. Hands-on experience in formulation development of oral solid dosage forms. Knowledge of QbD, regulatory guidelines, and process optimization. Strong analytical and problem-solving skills.

Basic Section No. Of Position 1 Grade ST Level Staff Organisational BUSINESS Metals BUSINESS_UNIT-1 Aluminium BUSINESS_UNIT-2 Chemicals Marketing BUSINESS_UNIT-3 Chemicals Muri DEPARTMENT-1 Integrated Health Services Country India State Jharkhand Worksite Muri, Ranchi Industry Manufacturing Function Health, Safety and Environment Skills Skill Occupational Health Nursing Treatment Planning Waste Management Clinical Pharmacy Emergency Management Billing Process Activity Coordination Team Building Interpersonal Abilities Safety WCM-Interwoven MIS & Analytics Minimum Qualification Bachelor of Nursing Degree Diploma in Nursing CERTIFICATION No data available About The Role About The Role Support Health, Safety & Environment Position: Support Health, Safety and Environment Location: Hindalco Industries Limited. Grade: JB 14 to JB12 Reports To: Chief Medical Officer/ Manager- Integrated Health Services Key Responsibilities: Periodic Medical Examination (PME): Assist in organizing and conducting PME for employees as per company and regulatory guidelines. Ensure proper record-keeping and follow-up on employee medical reports and re-examinations. Acrophobia Test: Administer acrophobia (fear of heights) tests to relevant staff and ensure proper documentation of results. Coordinate with the doctors and safety team to analyze and act on the test outcomes. Biomedical Waste Management: Oversee the correct disposal and management of biomedical waste as per safety and environmental regulations. Ensure compliance with local guidelines and company policies on biomedical waste. Pharmacy and Lab Inventory Management: Monitor, maintain, and manage pharmacy and laboratory inventories, ensuring that stocks are adequate for daily needs. Coordinate with purchase department for timely procurement and maintain accurate inventory records. Emergency Response Assistance: Assist in handling emergency cases by providing first aid, coordinating with healthcare providers, and ensuring timely response. Act as part of the emergency medical response team, ensuring preparedness for any workplace incidents. Claims and Billing Support: Help process medical and health claims for unionized employees, ensure timely and accurate claim submission. Maintain proper records of bills and claims for auditing and tracking purposes. Coordination with Visiting Specialist Doctors: Coordinate schedules and appointments for visiting specialist doctors. Ensure the smooth flow of information between specialists and employees. Health Status Communication: Inform employees, supervisors, and management about the health status of individuals as required, while maintaining confidentiality and adhering to privacy regulations. PME Follow-up: Track and follow up with doctors regarding employees for any required follow-up tests or medical procedures after PME. Ensure compliance with medical recommendations and timelines for assessments. Staff Duty Roster Management: Assist in managing and maintaining the duty roster for the staffs to ensure optimal coverage. Ensure that shift schedules meet operational requirements. Ambulance Management: Coordinate the management and scheduling of ambulances for emergencies and routine services. Ensure ambulances are properly maintained, stocked, and ready for use at all times. Qualifications: Diploma or degree in Occupational Health, Nursing, or Pharmacy. Certification in first aid and emergency response is preferred. Basic knowledge of healthcare administration, biomedical waste handling, and inventory management. Strong organizational and communication skills. Experience: Previous experience in occupational health, healthcare support, or a similar role is an advantage. Experience in handling medical emergencies and first aid will be an added advantage. Skills and Competencies: Attention to detail and ability to manage multiple tasks. Proficiency in basic computer programs (MS Office, inventory management software). Strong communication and coordination skills. Ability to handle sensitive health-related information with confidentiality. Ability to work in a team and collaborate with multiple stakeholders.

Role & responsibilities Managing Audit Committee of the Board (ACB) /Audit Committee of Executives (ACE) related activities Ability to handle pressure and meet meeting deadlines Ensuring compliance with Internal and regulatory guidelines Prepare presentations for Audit Committee Meetings Preparation and submission of error free minutes of the Committee within the prescribed time Comprehensiveness of the deliberations of Audit Committee meetings captured Accuracy of the ATRs based on the Audit Committee deliberations Timely preparation of Action Taken Report Ensuring directives / suggestions of ACB/ACE/Management are circulated within the organization /Department. Tracking directives / suggestions of ACB/ACE and seeking timely response from respective department and stakeholders Ensuring adherence to instructions / suggestions / directives given by SVP/CAE, Audit Committees from time to time. Submission of fortnightly/monthly/quarterly returns within prescribed times Ongoing engagement with various internal stakeholders on data requirements To adhere to all the processes related to the job role Preparing and Maintaining various database, tracker, correspondence, records etc. Timely Submission of data / information for onward reporting to Regulators, Audit Committee, Senior Management, etc. Preferred candidate profile Experience of 9-12 years in Banking industry 3-5 years of working experience in MS Office (Word, Excel. Power Point). Sound knowledge of Banking Operations Good communication (both verbal & written) and inter-personal skills Strong Excel and Power point presentation skills. Ability to handle pressure and meet deadlines of the meeting Ability to prioritize and make decisions in a fast-paced environment Ability to work as a part of team and contribute towards team goals Ability to manage multiple tasks/projects and deadlines simultaneously