Senior Regulatory Affairs Specialist

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