40 Regulatory Strategies Jobs

As a Regulatory Affairs Manager at our company in Gurgaon, Haryana (INDIA), your role will involve reviewing technical documentation for regulatory filings in various markets, such as the US, and conducting Gap Analysis and Remediation for module 3 -CMC. You will also be responsible for developing and implementing regulatory strategies, processes, and timelines for granting Marketing Authorizations in regions like Africas, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring compliance with regulatory guidelines and maintaining high-quality standards. - Critically examining documentation for submission, ensuring internal c...

Key Responsibilities JOB DESCRIPTION Your Responsibilities Include, But Are Not Limited To Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market. Draft controlled correspondences on complex issues. Draft Deficiency responses for Complex Products and 505(b)(2) Products. Review API and FP in-vitro characterization/sameness reports. DMF review for complex APIs as per the workflow. To collaborate and work closely with cross functional teams. Qualifications M...

Key Responsibilities JOB DESCRIPTION Your Responsibilities Include, But Are Not Limited To Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market. Draft controlled correspondences on complex issues. Draft Deficiency responses for Complex Products and 505(b)(2) Products. Review API and FP in-vitro characterization/sameness reports. DMF review for complex APIs as per the workflow. To collaborate and work closely with cross functional teams. Qualifications M...

Role Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned. Candidate should have minimum 10 years of experience into clinical data with 2+ years of experience into people manager. Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval. Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethica...

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance acr...

As an Assistant Manager Regulatory Affairs for EU & UK markets, your role involves driving CMC documentation, regulatory submissions, and lifecycle management to ensure compliance with regional and international guidelines. Your key responsibilities will include: - Conducting comprehensive CMC reviews of technical documentation for regulatory filings in the EU and UK markets. - Performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards. - Developing and implementing regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications. - Preparing and comp...

We are looking for a skilled Pharmaceutical Regulatory Affairs Advisor with 6-10 years of experience to join our team at Metina Pharmaconsuting, located in the Pharmaceutical & Life Sciences industry. Roles and Responsibility Develop and implement regulatory strategies for pharmaceutical products. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct thorough reviews of regulatory submissions and documents. Provide expert guidance on regulatory affairs matters. Stay updated with changing regulatory environments and trends. Ensure timely submission of regulatory documents to meet business objectives. Job Requirements Strong knowledge of pharmaceuti...

As a Drug Regulatory Affairs Specialist at Medyur Pharmaceuticals Limited, you will be responsible for ensuring compliance with regulatory requirements for our products and driving successful product launches. You will collaborate with cross-functional teams to maintain regulatory compliance and facilitate smooth communication with regulatory bodies. Key Responsibilities: - Prepare and submit regulatory documentation such as dossiers for pre-market submissions to obtain necessary approvals. - Stay up to date on current regulatory requirements, guidelines, and industry trends in global markets. - Develop and maintain strong relationships with regulatory bodies to support approvals. - Review c...

As a Regulatory Affairs Manager for biologic products, your responsibilities will include: - Developing global regulatory strategies for biologic products throughout all development phases in the US, EU, and rest of the world, ensuring alignment with business objectives and regulatory requirements in different regions (FDA, EMA, emerging markets). - Preparing, reviewing, and managing high-quality regulatory submissions such as INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, and post-approval changes (variations, amendments). - Engaging with global regulatory agencies to support product approvals and address inquiries, collaborating with R&D, Quality, Clinical, and national regulatory teams t...

Site Name: UK London New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, Warsaw Posted Date: Oct 27 2025 Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines Join our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Group within Global Regulatory Affairs at GSK, where we play an essential role in ensuring uninterrupted access to life-changing medicines for patients worldwide. As part of the CMC Regulatory Affairs team, you'll collaborate across Global Supply Chain (GSC), Technical, Quality, and Local Operating Companies to support lifecy...

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance acr...

Role Overview: You will provide medical expertise for site identification, study feasibility, study design, conduct, analysis, and reporting. Your responsibilities will also include the generation of integrated databases, pooled analyses for efficacy and safety, ISE and ISSs, as well as dossiers for regulatory submissions for market authorizations of new medicinal products, diagnostics, and devices. Key Responsibilities: - Define regulatory strategies for submission of clinical trial applications, approval, and marketing trial applications in targeted regions such as India, U.S, and EU. - Prepare and review regulatory documents, dossiers containing technical, preclinical, and clinical data i...

As an Engagement Manager (Consulting) at PharmaACE, you will lead multiple end-to-end consulting engagements focused on the life sciences, particularly the pharmaceutical and biotechnology industries. Your role will involve partnering with senior executives and cross-functional teams to solve complex business challenges, develop data-driven strategies, and deliver high-impact insights that support implementation and ensure measurable value. Your goal will be to assist clients in developing and implementing strategies for growth and market leadership. Responsibilities: - Act as the pivotal, central point of contact for the client/pharma company for all respective engagements. - Develop and tr...

Role Overview: As a Regulatory Affairs Specialist at Amneal, your primary responsibility will be to prepare regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, and 505(b)(2) products for both the US and EU markets. You will be drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will review API and finished product in-vitro characterization reports, collaborate with cross-functional teams, and ensure compliance with regulatory standards. Key Responsibilities: - Prepare Regulatory strategies for Complex Products including injectables, peptides, microspheres, lipos...

As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include: - Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market - Performing Gap Analysis and Remediation for module 3 -CMC - Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN - Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guideline...

As the Regulatory Head at our company located in Gurugram Analytical Lab near CRPF Camp, Gate No 1, Kadarpur Road, Gurgaon, Haryana - 122102, your role will involve developing and implementing regulatory strategies to support product development and market entry in compliance with global regulatory standards. You will lead the regulatory affairs department, ensuring timely submission of regulatory documents and approvals. Your responsibilities will also include ensuring that all company products meet regulatory requirements and are compliant with the laws and standards of the respective markets. Key Responsibilities: - Develop and implement regulatory strategies for product development and m...

As the Manager Regulatory Affairs at Kenvue, you will lead a team responsible for developing regulatory strategies across India, providing guidance on local requirements to product development teams. Your responsibilities will include managing regulatory deliverables for various products within your geographical and brand area, ensuring consistency in regulatory positions, and maintaining current products throughout their lifecycle. You will also represent the Regulatory Affairs function within the Franchise. Key Responsibilities: - Provide regulatory input and guidance to product development teams - Support business initiatives by influencing and approving the product portfolio - Conduct ri...

As a Manager - Business & Regulatory at Visakhapatnam with 10+ years of experience in the Finance domain, your role will involve the following key responsibilities: - Developing and implementing regulatory strategies to ensure compliance with industry standards - Managing CAPEX and OPEX budgets effectively - Creating and maintaining tariff models for financial planning - Conducting financial modelling to support decision-making processes To excel in this role, you are required to have: - MBA in Finance and BE qualification - Proficiency in CAPEX, OPEX, tariff modeling, and financial modelling,

As a Regulatory Affairs Director at Azurity Pharmaceuticals, your role involves ensuring the development and implementation of effective regulatory strategies for projects in development and approved. You will be responsible for providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, as well as leading the execution of regulatory strategies for pre-approval and post-approval activities. Your oversight of regulatory team activities will include managing filings, conducting technical reviews of documents, and ensuring regulatory compliance. - Develop and implement robust regulatory strategies and plans for projects, ensuring regula...

Key Accountabilities Propose efficient regulatory pathway for New Product Introduction ? Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs ? Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc. related to new products filing ? Collaborate with other functions such as R&D, Quality, Supply chain, Project Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with business priorities ? Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to CDSCO (Central Drugs Standard Control Organization), State FDA etc. ? Wel...

Role Overview: As a Regulatory Affairs Specialist at the company, your main responsibility will be to prepare, review, and finalize regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, DDCP, etc., along with 505(b)(2) products for regulated markets like the US, Canada, and EU. You will be drafting, reviewing, and finalizing various regulatory documents including Pre-ANDA/Pre-IND/ScA/Scientific meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will collaborate with cross-functional teams, meet management expectations regarding timelines and quality, and provide training to new team members o...

Responsibilities: Supports the Northern Cluster team (as appropriate) for UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio. Supports the team with regulatory strategies (local and regional) that are in line with the business plan Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to: Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand) Supports ad hoc projects (e.g., compliance review...

As a Regulatory Affairs Specialist, you will be responsible for maintaining accurate records of regulatory submissions, approvals, and correspondence with regulatory agencies. You will have the following key responsibilities: - Prepare, review, and submit regulatory documents, including applications, reports, and renewals, to relevant regulatory agencies. - Determine the types of regulatory submissions or internal documentation required for situations such as proposed device changes. - Develop and implement regulatory strategies to ensure compliance with domestic and international regulatory requirements. - Monitor regulatory changes and updates closely, assess their impact on current and fu...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparation...