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.
