Regulatory Affairs Associate

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!