(Only 24h Left) Regulatory Affairs Associate

3 days ago

Nagpur, India Peoplefy Full time

Hi Everyone,

I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.

Please refer below JD and share your profile on pallavi.ag@peoplefy.com

- Experienced in preparing, review and compile regulatory submissions.
- Maintain compliance with US FDA and ICH requirements.
- Should have experienced in pre-submission activity.
- Experienced in CMC.
- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.
- Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines.
- Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
- Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
- Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
- Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses.
- Review and approve change controls from global manufacturing partners to assess regulatory impact.
- Stay current with FDA guidance, ICH regulations, pharmacopeial requirements, and industry updates.

Thank you

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