Regulatory Affairs CMC Associate (US Market)

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 :

Skills Required

Microsoft Word, Excel, Microsoft Office Suite