Senior Regulatory Affairs Specialist
Job Summary
To support global regulatory strategies, the part-time Senior Regulatory Affairs Specialist will lead and execute regulatory submissions, draft high-quality documentation, and facilitate communication with health authorities while working remotely.
Key Responsibilities:
- Author and compile CMC sections of regulatory applications, including INDs, IMPDs, and CTAs
- Draft and maintain CMC regulatory documents such as Module 2 and 3 summaries and stability reports
- Prepare responses to CMC-related questions from global health authorities to support regulatory interactions
Required Qualifications:
- B.A., M.S., or Ph.D. in biochemistry, chemistry, biology, or a related pharmaceutical field
- Minimum of 10+ years of experience in CMC/regulatory affairs
- Hands-on experience with authoring and compiling CMC sections of regulatory filings
- Strong knowledge of global CMC clinical regulatory requirements and guidelines
- Proficiency with regulatory document management systems
Complete Job Description
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