Regulatory Affairs Specialist (CMC)

Responsibilities

• Prepare, author, review, and compile CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, ANDAs, MAAs)
• Support the preparation of amendments, supplements, annual reports, and variations
• Ensure all CMC documentation complies with regional regulatory requirements (FDA, EMA, ICH, etc.)
• Manage and maintain regulatory dossiers in electronic submission formats (eCTD)
• Contribute to the development and implementation of CMC regulatory strategies throughout the product lifecycle
• Support preparation of responses to regulatory agency questions and deficiency letters
• Participate in inspections and audits as needed
• Collaborate closely with Quality, Manufacturing, Supply Chain, and R&D teams to gather and verify accurate CMC data
• Track submission timelines and ensure timely delivery of regulatory documents

Qualifications

• 2–5+ years of experience in regulatory affairs, preferably with a focus on CMC
• Experience with regulatory submissions in the pharmaceutical or biotechnology industry
• Familiarity with global regulatory requirements (FDA, EMA, ICH guidelines)
• Strong knowledge of CMC processes including drug substance and drug product development
• Experience with eCTD submission systems and document management tools (Veeva)
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field required

Pay

Salary: $60,000 - $85,000 annually, commensurate with experience

Benefits

• Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays
• 1 hybrid day per week