50 Regulatory Guidelines Jobs

Overall Job Description Investigations Adherence to the timelines for completion of Vigilance investigation. - To conduct investigations into verifiable allegations reported during the course of the year and / or complaints received/assigned by CIV and submission of reports for further consideration of the Disciplinary Authority. Completion of investigation and submission of reports within stipulated timelines. Adherence to regulatory requirement / internal policies- Ensure adherence to the regulatory requirements / internal guidelines with regards to conducting and conclusion of investigations. Comprehensiveness and quality of investigations Focus on Root Cause Analysis, Identification of Process / Control Gaps. - Provide qualitative recommendations for improvement of processes. - Identification and fixing of Staff Accountability. - Maintaining evidences, records & documentation pertaining to investigations. - Quality of notes placed to the committees. Preventive Vigilance Assimilating intelligence through surveillance and detection about corrupt practices committed or likely to be committed by employees of the Bank which inter alia includes reviewing available information in public domain/other bank cases/ newspaper reports and providing necessary insights to the CIV from a preventive vigilance perspective. Conducting Training & Awareness programs. MIS, Reports & Process Preparing monthly/Quarterly/Annual memos for review of Vigilance Committee, Audit committee and board. Preparing MIS & Dashboards for circulation to stakeholders Creating and maintaining central repository for Vigilance Department. Reviewing staff accountability cases to identify cases with a vigilance angle. Conducting reviews/ study of processes with a vigilance perspective. Drafting responses to regulatory authorities/ stakeholders. Ensuring Banks Vigilance / WBM Policy are totally in sync with all statutory and regulatory guidelines. Keep abreast of the latest regulatory guidelines and circulars and ensure adherence to the same.

Location- Novo Nordisk Global Business Services (GBS), Ahmedabad, India Department- GCM Operations Drug Product Are you ready to take charge and make a difference in the pharmaceutical industryIf you’re a dynamic person with a passion for quality and operational efficiency, you might be our new Operations Manager. The position is based in Ahmedabad in India and will report directly to GCM organization based in Denmark. Apply today and get life changing career! Apply now! The position As an Operations Manager, you will be responsible for ensuring Novo Nordisk’s interests with regards to short to midterm capacity, compliance, quality, manufacturing readiness and activities at the CMO. You will have a substantial impact on the business with the CMO with regards to strategy input, prioritization and following up on agreed actions and improvements. Your other responsibilities will be to: Responsible for short to midterm capacity, compliance, quality, manufacturing readiness and activities at selected CMOs ensuring timely delivery of products to downstream customers with a strong focus on production performance and quality. Developing and following up on joint KPI’s and creating a robust working relation with the CMOs. Identify and implement changes and process improvements at CMOs in order to create a strong and solid foundation for future growth in this area. Develop new work standards and setups for collaboration between GCM DP and relevant CMO’s delivering aseptic manufacturing activities. Participate in project work to the extent needed to ensure new projects/CMOs enter operations in a satisfactory manner. Approximately 3–5 weeks of travel per year is expected as part of this role. Qualifications To be successful in this role, you should have: Master’s or Bachelor’s degree in Engineering, Pharmacy, or a Supply Chain-related field, with excellent written and verbal communication skills and a strong command of English 10 years of experience within pharmaceutical manufacturing / packaging and cGMP and 5 years of experience with outsourcing or managing global CMOs. Experience in Production, Manufacturing Operations, Project management or Supply Chain management. Experienced in handling Changes, Deviations, and Customer Complaints, with strong knowledge of regulatory guidelines in the pharmaceutical industry, excellent relationship management skills, and a solid understanding of GxP principles. Team player demonstrating collaborative behavior, effective communicator providing clear and timely information to stakeholders, with a technical, analytical, and structured approach to problem-solving. About the Department Global Contract Manufacturing Drug Products (GCM DP) oversees all aspects of commercial external production, including filling, assembly and packaging. We prioritize diversity, encourage empowerment, and pride ourselves with a varied workforce, comprising a range of professional profiles such as project managers, supply chain professionals, specialists and operation managers.

As a A Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4)/ Associate Vice President(M5) The key responsibilities would include the following Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

As a A Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4)/ Associate Vice President(M5) The key responsibilities would include the following: Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

Business Unit PSL Product Team – Corporate, Institutional & Investment Banking PSL Product team takes care of entire priority sector lending portfolio for Corporate, Institutional & Investment Banking group. PSL product team is responsible for Identification, classification and reporting of Priority Sector book. The team is also responsible for working out structuring for various PSL deals in close co-ordination with Business units. Role PSL Product Manager Objective To drive Priority Sector Lending business, ensure accurate classification and reporting of PSL assets in Wholesale banking business Responsibilities PSL Reporting, PnL Management & Portfolio Management Ensure PSL reporting is completed timely and in adherence to extant regulatory guidelines and updation of Product notes or assigned products in line with change in regulations/RBI/SIDBI/Ministry of MSME etc. Managing the PSL portfolio of Wholesale banking and internal/external audits for this portfolio Drive projects for digitisation/ automation of PSL reporting Manage PnL for PSL portfolio of Wholesale banking Driving PSL Book Growth Drive PSL book growth for WBG organically & inorganically by way of Corporate linked PSL structure, securitization / on-lending etc. Generate vendor Financing and Agriculture PSL leads. Meet clients, structure PSL deal and conclude the same in close co-ordination with Relationship Team Prepare Program note incorporating PSL complaint structures and arrange approval from requisite sanctioning authority To execute client/ vendor (Farmer level) documentation in close co-ordination with on filed SeSo official and/or Business Correspondent Review PSL process note for process upgradation from time to time Due Diligence Conduct due diligence of PSL proposal post disbursement, by sample audits based on requirement. Drive PSL - to build mindshare towards PSL: Explore PSL opportunities in corporate banking Conduct trainings & reviews with Business team Experience CA/ MBA with 3-6 years of experience. Some experience in similar field is added advantage. Essential competencies - Flair to work in Priority Sector Lending Group - Good communication skills - Ownership, Result oriented , growth mind-set. Base Locations Kotak Mahindra Bank Mumbai

Role – Team member – Compliance Experience – 5 years Grade – M5/M6 Qualification – CA/MBA Keeping track of updates in regulatory guidelines applicable to company, assess the impact on processes/policies and ensure implementation of changes. Driving compliance culture in organization and ensuring compliance with existing RBI guidelines Advising Business/credit on compliance related matters. Providing clarification to various stakeholders on compliance queries Maintaining policies of organization and ensuring periodic review of same as per regulatory/internal guidelines Submission of periodic RBI returns and responding to ad-hoc RBI data requirements Liaise with group company on compliance related matters and submission of periodic/ad-hoc data to group company Performing compliance reviews for different departments and periodical test checking of Internal Controls of the company Monitoring the compliance system of company and ensuring compliance of respective stakeholders on timely basis in system One point of contact of RBI and managing Internal/Statutory audits and RBI Inspections.

Role & responsibilities Take care of IT compliance & also conduct Information Systems Audit for the Bank. Experience in conducting Information Systems and Security audits, application control reviews and application functionality reviews Need to perform IT audits as per the agreed annual audit plan. Practical experience of audit methodology Assisting the team members in conducting compliance reviews. Assist in preparation of monthly / quarterly / annual submission to the Board / Audit & Compliance Committee. Essential competencies In depth knowledge of the regulatory environment for the banks in India particularly RBI & FEMA requirements. Good Co-ordination skills. Good research capabilities and intelligent interpretation of regulatory guidelines. Good knowledge of all the elements (commercial, operational) of banking areas like Trade, Remittances, Treasury e.t.c. Relevant experience: 1-2 years post qualification experience in Financial Services environment, preferably in handling RBI Inspection Impeccable integrity and compliance consciousness.

Role & responsibilities Assistance in preparation of Compliance Review plan to be put up to the Board. Preparation and updating of Compliance review checklists in line with the regulatory guidelines/internal policies. Undertaking field work and ensuring that the review is completed within the prescribed timelines. Preparation of Draft Compliance Review report and discuss the same with the relevant stakeholders. Obtain the responses from the stakeholders and preparation of Final Compliance Review Report. Ensure proper documentation and working papers are maintained for all the compliance reviews conducted. Preparation of Open Issue tracker for Compliance Review Reports issued. Follow up with the management towards closure of compliance review open issues. Essential competencies In depth knowledge of the regulatory environment for the banks in India particularly RBI. Good research capabilities and intelligent interpretation of regulatory guidelines. Good knowledge of all the elements (commercial, operational) of banking areas like Trade, Remittances, Treasury, etc. Good interpersonal skills.

Role & responsibilities Cash and Vault monitoring in branch Ensure adherence with laid down processes and controls and manage Operational Risk for the Branch. Ensure, manage and supervise over the counter services in the branch to achieve timely and accurate processing of customer requests transactions and customer complaints, while ensuring service delivery is as per the prescribed standards and SLAs between the functions of the bank. Adherence to agreed TATs with Business thereby ensuring customer satisfaction. Compliance with all regulatory and internal guidelines and policies Manage audit at Branch and always ensure minimum satisfactory rating. Ensure smooth functioning of the Branch by supervising activities relating to Facilities Management, IT, etc. at branch level. Manage & control all operational functions of the Branch and define roles and responsibilities clearly for all team members. Ensure adequate coordination with centralized operations teams to maintain high quality service and customer satisfaction. Ensure timely receipt and submission of regulatory and other reports by/from the Branch. Monitor SLAs with all the Central Operations units. Participate in all critical system enhancement and process improvement exercises within Trade & Operations. Identify areas where productivity enhancement and cost reduction initiatives can be introduced. Ensure all processes are performed as per bank policies to achieve best satisfactory audit ratings in internal, external and SBP audits. Lead the branch Operations team to set individual objectives, review performance appraisals and provide on-going feedback on a formal and informal basis so that all staff are aware of what they are required to achieve and how they are performing against their objectives. Ensure implementation of a transparent and effective KPIs setting and appraisal process in time with local and regional guidelines. Actively participate for retention of deposits, identify and follow up on cross sell leads along with the branch manager in order to strengthen the liability position of the bank Have complete knowledge of the customer base in terms of the profile, demographics & psychographics and assets in the Bank and in other places. Any other responsibilities as assigned by Head T&O from time to time.

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred

As part of a global team, you will be the second level contact to support our commercial organizations/customer facing functions with quality & regulatory knowledge for our global Life Science product portfolio. You will assist and advise our customers on quality and regulatory topics such as but not limited to providing consultative services and documentation support. You will interact with various internal functions (e.g. Quality, Regulatory, Business) to come up with resolution to address our customers Quality (Q) & Regulatory (R) related inquiries. Being the interface between customers and our internal functions, you will give advice to our customers as well as our internal stakeholders, explain complex topics including to non-experts and support the development of market leading solutions. Create/Continue to improve our digital solutions and workflows with aim to achieve better customer satisfaction. As a Subject Matter Expert for a specific group of product portfolio and/or Quality/Regulatory topic, you will drive the continuous improvements and implementation of digital workflows to improve our service level support. Who You Are: Masters Degree in Life Sciences, Chemistry, Biology, or equivalent. Minimum 4 years professional working experience in a customer service-oriented environment in Life Science, Biotechnology, or related industry. Good understanding of quality & regulatory guidelines is a plus especially for pharmaceutical raw materials (e.g. Excipient & API). Digital savvy in using digital tools are necessary and important in daily work. Proficiency in using relevant software applications such as SFDC, SAP & Microsoft 365. Act as a voice of our customers by advocating the importance to support when necessary and work with relevant stakeholders to find feasible solutions to resolve challenges faced. Global mindset and willing to attend global calls outside office hours (e.g. night calls). APAC regional exposure experience will be an added advantage.

Role & responsibilities Capgemini Invent is looking for candidates who have the right mix of Domain & Management experience to join our Data-driven FRC Pre-Sales track. The role will require the following: Primarily responsible for all activities leading in pre-sales, initial client communication & understanding the business and operational goals of our clients. Present and demonstrate end-to-end capabilities to all required point-of-contacts and prospective clients. Create Offers/Client Pitches/Business Proposals, respond to RFQs/RFPs and create quick proofs-of-concept / custom demos/integrations to help the sales team drive deal closures. To deliver a high-quality experience to the prospects & customers during engagement, acquisition, and onboarding. Present and demonstrate end-to-end capabilities of our solution accelerators to all required point-of-contacts and prospective clients. Participate actively and deliver Knowledge Sharing Sessions & Training to internal teams/partners. Domain Role: Conduct robust model validation, stress testing, and calibration processes to ensure accuracy and compliance with regulatory standards. Assess and quantify model risk by developing alternative benchmark models. Oversee monitoring of ongoing model performance Communicate validation outcomes to key stakeholders and management. Stay up to date with industry trends, academic research, and regulatory changes affecting rate derivatives and quantitative modelling Maintain detailed documentation of model assumptions, methodologies, and performance metrics, ensuring models meet internal audit and regulatory standards. Should be willing to take on a committed engagement role or client-facing advisory/delivery responsibilities while implementing our offers/solutions with our local and/or global teams. Should be able to conceptualise and lead the development of offers and consulting assets to support pre-sales, GTM pursuits and capability demonstrations. Core Competencies: Relevant experience in the financial services industry with either a consulting firm, internal consulting organization, or within Risk Analytics or Model Risk Management (MRM) function Demonstrate derivatives product knowledge across asset classes including interest rates, credit, equity, commodity, and FX, including pricing and valuation models Strong communication and interpersonal skills, with the ability to interact at all levels of the organization. Experience with the configuration or implementation of any major Risk Management platforms or solutions will be a plus Knowledge of banking and regulatory processes including SR 11-7, SS 1/23, CCAR/DFAST, IRB models and FRTB Excellent presentation and demonstration skills, addressing all key pain points of the client at hand. Excellent aptitude, problem-solving skills, and quick prototyping / proof -of-concept-creation skills. Should be passionate about customer-facing roles. Ability to grasp new technologies and drive executions quickly. Qualifications: Masters or Ph.D. in Quantitative Finance, Mathematics, Physics, Statistics, or a related field with 10+ years of relevant experience. 6-8 years of experience in a Pre-sales role. Certifications such as FRM, CQF, CFA, PRM Deep understanding of interest rate products and derivatives, including pricing models like the Black-Scholes, SABR, HJM, and Hull-White models. Strong problem-solving abilities and attention to detail with the ability to work in a fast paced, high-stakes environment Effective communication skills, with experience in writing clear and concise model documentation Valid Business Visa (B1 or H1) for travel to US

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product / Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process / Digital Journey"™s / new initiatives / features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

Title : GXP Validation Testing | 4 to 18 years | Mumbai, Pune, Hyderabad & Bengaluru Design, develop, and execute test cases, test scripts, and test plans based on project requirements. Conduct functional, regression, integration, and acceptance testing. Track and document defects, issues, and ensure timely resolution. Collaborate with cross-functional teams to understand requirements and provide feedback on system designs. Ensure all manual testing activities are documented according to company policies and standards. Apply GXP testing practices (Good Laboratory Practices, Good Manufacturing Practices, Good Clinical Practices) to ensure software meets regulatory compliance and industry standards. Participate in audits and inspections for compliance with regulatory guidelines. Review and verify that systems and software adhere to FDA, EMA, and other regulatory body standards. Ensure traceability and validation of test results in a controlled environment. Job Description - Grade Specific GXP Validation Testing Life Science Domain experience

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

1. Preparation and review of Drug Master Files, Dossiers as per regulatory guidelines. 2. Ensuring compliance with regulations set by the authorities. 3. Keeping up to date with changes in regulatory legislation and guidelines. 4. Analyzing complicated information & data provided by other departments, including trial data. 5. Ensuring that quality standards are met and submissions meet strict timelines. 6. Coordination with QA, QC & R&D to get documentation required for preparation of Drug Master Files & Technical dossiers. 7. Responsible for DMF/Dossier updations, revisions. 8. Responding to Customers and Regulatory Authorities on technical queries in time. 9. Maintaining customer correspondences.

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.

Experience: 5+ year of experience in fintech industry specially from payment getaway/UPI. 1.Must having knowledge for getting license form RBI for payment getaway. 2.Regulatory Compliance: Advising on compliance with financial regulations like AML (Anti-Money Laundering), KYC (Know Your Customer), and consumer protection laws, as well as data protection laws. 3. To ensure compliance with all the laws, rules, regulations, circulars, directive etc applicable to a Payment system operator, knowledge about Banking and Escrow including applicable RBI circulars. 4. Implementation of compliance calendar with respect to the various provisions of Company Law, Rules and Regulations, Corporate Governance Code, RBI guidelines, and provisions of various laws, rules and regulations as may be applicable to the company. 5. To keep the business and relevant stakeholders updated on the new amendments, circulars, change in regulations etc. 6.Contract Drafting and Negotiation: Drafting, reviewing, and negotiating various contracts, including those related to technology licensing, payment processing, data sharing, and vendor relationships. 7.Risk Management: Identifying and mitigating legal risks for FinTech companies, ensuring compliance with applicable laws and industry best practices. Skills that will help you succeed in this role : 1. Overall 5+ years of experience in which at least 2+ in fintech business. 2. Should be familiar with Indian regulatory landscape i.e. RBI,SEBI. 3. Audit experience will be plus. Educational Qualifications Required: LLM/LLB would be preferred.

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Job Purpose: This role is responsible for the development and design of methodologies and standards for review activities across the products in alignment with Compliance Risk Framework. Testing, validation, and documentation of review activities for new and existing products and controls according to standards and other applicable policies. Overseeing the effective implementation of testing observations, tracking and closure of all compliance requirements by coordinating with respective functions. Owning projects and tracking, preparing Compliance dashboards for reviews and implement action points, building and maintaining healthy business relations with external and internal customers. Key Responsibilities Functional Responsibilities Outcome of Risk assessment Compliance control point shall be defined, and testing will be carried out. Planning and execution of Compliance testing. Establish and maintain comprehensive compliance testing programs to identify, assess, and highlight compliance risks. Monitor and test compliance by performing sufficient and representative Compliance testing and result of such compliance testing shall be reported to the Senior Management. Track Compliance testing observation open points, coordinate with respective team for implementation and track until closure of testing. Responsible for executing the proposed Compliance projects. Support the reporting manager on regulatory reporting. Support the reporting manager in handling / preparedness of RBI inspection like Co-ordinate with respective team, data collection, review the documents and Finalization of RBI datas, day to day RBI Correspondences, returns filing and circulation of Compliance MIS. Job Requirements Qualifications: CA / CMA /Any graduate Experience 2 - 5 Years relevant experience in Compliance / Internal audit / Internal Control from Banks / NBFC s / Consulting Functional Competencies Drive and initiative, strong commitment, ability to take ownership, Analytical acumen, eye for details, Smart thinkingHigh level of integrity, professionalism, and attention to detailExp in handling various projects Behavioral Competencies Strong Analytical, Interpersonal and Convincing skillsStrong communication and interpersonal skillsProblem solving and decision-making skillsPeople management and networking skills

Role & Responsibilities:- Assist in conducting audit engagements to ensure compliance with standards and frameworks such as ISO 27001, PCI DSS, SOC 2, and GDPR. • Support the planning, execution, and reporting of audits under the supervision of senior auditors. • Gather and analyze evidence to evaluate client compliance and provide initial recommendations. Detailed Responsibilities • Conduct audits based on defined standards, collecting and verifying evidence. • Perform control testing, evaluate processes, and identify compliance gaps. • Assist in evaluating policies, procedures, and systems for compliance • Draft sections of audit reports with findings, observations, and initial recommendations. • Maintain accuracy and completeness in audit documentation, following the organization's standards. • Support in preparing final audit deliverables for senior review • Communicate with client representatives during evidence collection. • Participate in meetings to discuss audit findings and recommendations. • Assist in tracking client remediation actions. Professional Skills:- • Basic understanding of audit standards and regulatory frameworks (e.g., ISO 27001, SOC 2). • Competency in using audit tools and software (e.g., spreadsheets, document management systems). • Strong analytical skills for evidence evaluation and compliance assessment. Personal Skills:- • Attention to detail and accuracy in documenting findings. • Good communication skills for interacting with team members and clients. • Willingness to learn and adapt to new standards and regulations. Knowledge/Competency Requirements:- • Basic knowledge of auditing principles, risk assessment, and compliance. • Understanding of industry standards relevant to information security and data privacy. • Competency in basic project management tasks, such as tracking timelines and deliverables

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.