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Global Regulatory Affairs Meril

5.0 - 9.0 years

0 Lacs

vapi, gujarat

On-site

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...

Posted 5 days ago

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