Biologics Regulatory Strategist

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 across product lifecycle.

7. Provide regulatory guidance during product development, tech transfer, and clinical trial execution, as appropriate.

8. Monitor and interpret evolving global regulations, guidelines, and industry trends related to product category.

9. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.

Qualifications :

1. Master’s degree (M.Sc. / M.Pharm / M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.

2. Minimum 5-7 years of regulatory affairs experience, with a strong focus on biologics (including mAbs, biosimilars, vaccines, or novel biologics) in the emerging markets.

3. Solid understanding of ICH guidelines, FDA, EMA, and other emerging market regulatory frameworks.

4. Experience in IND / BLA submissions, and lifecycle management of biological products.

Note :

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