Regulatory Affairs Associate

4 weeks ago

New Delhi, 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.comExperienced 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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