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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