Regulatory Affairs Executive Micro Crispr Pvt. Ltd.

5.0 - 7.0 years

0 Lacs

vapi, gujarat, india

On-site

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...

Posted 2 weeks ago

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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 4 weeks ago

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Global Regulatory Affairs Meril

5.0 - 7.0 years

0 Lacs

vapi, gujarat, india

On-site

Posted 1 month ago

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Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying up...

Posted 1 month ago

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Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

Posted 3 months ago

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