Global regulatory affairs
4 weeks ago
Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory submissions includingINDs/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 ensureregulatory compliance across product lifecycle.7. Provide regulatory guidance during product development, tech transfer, and clinical trialexecution, as appropriate.8. Monitor and interpret evolving global regulations, guidelines, and industry trends relatedto product category.9. Provide interpretive analyses of regulatory guidance, regulations, or directives thatimpact 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 m Abs, biosimilars, vaccines, or novel biologics) in the emerging markets.3. Solid understanding of ICH guidelines, FDA, EMA, and other emerging marketregulatory frameworks.4. Experience in IND / BLA submissions, and lifecycle management of biological products.
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Manager Global Regulatory Affairs
1 day ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
1 day ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
1 day ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
1 day ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
1 day ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
2 days ago
Vapi, Gujarat, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experiencedRegulatory Affairs professionalto lead and executeglobal regulatory strategiesfor biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals acrossUS, EU,...
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Global Regulatory Affairs
3 weeks ago
Vapi, Gujarat, India, Gujarat Meril Full timeKey Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...
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Regulatory Affairs Executive
4 weeks ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey 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...
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Regulatory affairs executive
4 weeks ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey 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...
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Regulatory Affairs Executive
5 days ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey 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...
