Regulatory Affairs Global CMC Lead
1 month ago
EPM Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team as a Global CMC Submissions Lead. As a key member of our Regulatory Affairs team, you will be responsible for supporting day-to-day Regulatory Affairs activities and addressing external customer requests.
Key Responsibilities:
- Prepare global regulatory documentation and registrations to support business objectives and goals.
- Develop and maintain Drug Master Files (DMF) for U.S. FDA and similar documents for other countries as necessary.
- Stay informed on current regulatory requirements for drug substances and Active Pharmaceutical Ingredients (API) in the EU.
- Remain knowledgeable about Code of Federal Regulations (CFR) for DMF, Investigational New Drug (IND), and New Drug Application (NDA) submissions.
- Prepare documentation packages for clients to support DMF, IND, and NDA submissions.
- Collect, review, interpret, and summarize data, deviations, change control records, and other relevant documentation for Annual Updates per company procedures.
- Serve as a Regulatory Affairs advisor to the Change Control Committee and other quality improvement task forces.
- Assist Contract Manufacturing and Research & Development teams with regulatory functions.
- Utilize electronic submission formats, such as Electronic Common Technical Document (ECTD).
Requirements:
- Minimum of 3 years of experience in Regulatory Affairs; 10 years preferred.
- Bachelor's degree in a scientific or pre-professional field required; advanced degree or regulatory certification preferred.
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