Regulatory Affairs Associate

4 weeks ago

Navi Mumbai, 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 - 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

  • Regulatory Affairs Associate

    1 week ago

    Navi Mumbai, Maharashtra, India Peoplefy Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We're Hiring: Regulatory Affairs – CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or...

  • Regulatory Affairs Associate

    3 weeks ago

    Navi Mumbai, 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...

  • Regulatory Affairs Associate

    4 weeks ago

    Navi Mumbai, 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 Experienced in preparing, review and compile regulatory submissions.- Maintain compliance with US FDA and ICH requirements.- Should have experienced in pre-submission activity.-...

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    2 weeks ago

    navi mumbai, 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...

  • Regulatory Affairs Associate

    3 weeks ago

    Navi Mumbai, 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...

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    1 week ago

    Navi Mumbai, Maharashtra, India Peoplefy Infosolutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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  • Regulatory Affairs Associate

    4 weeks ago

    Navi Mumbai, 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 Experienced in preparing, review and compile regulatory submissions. Maintain compliance with US FDA and ICH requirements. Should have experienced in pre-submission...

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    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per year

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