Regulatory Affairs CMC Associate

2 days ago

Mumbai, Maharashtra, India Ztek Consulting Full time

Job Description – Regulatory Affairs CMC Associate (US Market)

We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.

Key Responsibilities:

  • 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, pharmacopoeial requirements, and industry updates.

Requirements:

  • Bachelor's/Master's degree in Pharmacy, Life Sciences, or related field.
  • 3 to 7 years of experience in Regulatory Affairs, preferably with US FDA submissions.
  • Strong knowledge of eCTD submissions, CMC requirements, and US labeling.
  • Excellent oral and written communication skills
  • Ability to work independently and in a team environment
  • Proficiency in Microsoft Office Suite with Microsoft Word and Excel
  • Detail-oriented, with excellent communication and cross-functional collaboration skills.

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