Senior Regulatory Affairs Specialist

A company is looking for a Senior Regulatory Affairs Specialist (Remote).

Key Responsibilities

Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports

Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols

Develop CMC regulatory strategies to support clinical trial initiation and advancement

Required Qualifications

B.A., B.S., 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 authoring and compiling CMC sections of regulatory filings

Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH

Proficiency with regulatory document management systems