My client is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, my client has specialized in the development and cGMP-compliant manufacturing of Active Pharmaceutical Ingredients (APIs). They have an exciting opportunity to join the team as an on-site Lead Regulatory Affairs Specialist - Global CMC Submissions.
This on-site position is responsible for supporting day-to-day Regulatory Affairs (RA) activities at my client, as well as addressing external customer requests. Responsibilities include maintaining and responding to established timelines for reports such as Drug Master Files (DMF) and annual updates/amendments in compliance with ICH Q7, 21 CFR 314.420, and other applicable regulations. Strong oral and listening communication skills are required to support both external and internal customers, as well as regulatory agencies. Exceptional writing skills for technical subjects and regulatory documents are essential. Attention to detail and the ability to work independently with minimal supervision are required.
Responsibilities:
- Prepare global regulatory documentation and registrations to support client objectives and business 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).
Qualifications:
- Position may be filled up to the Lead level, determined at the hiring manager's discretion.
- Minimum of 3 years required; 10 years preferred.
- Bachelor’s degree in a scientific or pre-professional field required; advanced degree or regulatory certification preferred.
