Regulatory Affairs Specialist (CMC)

Piper Companies is seeking a Regulatory Affairs Specialist (CMC) to support a well-established biotechnology client out of the Durham, NC area. The Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions.

Responsibilities of the Regulatory Affairs Specialist (CMC):

• 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 of the Regulatory Affairs Specialist (CMC):

• 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

Compensation for the Regulatory Affairs Specialist (CMC):

• Salary: $60,000 - $85,000 annually, commensurate with experience
• Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays

o 1 hybrid day per week

This job opens for applications on 6/26/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

CMC, Chemistry, Manufacturing & Controls, Regulatory Affairs, Regulatory Strategy, Global Regulatory Submissions, Drug Development, Development Lifecycle, Product Lifecycle Management, Regulatory Compliance, IND, Investigational New Drug, NDA, New Drug Application, BLA, Biologics License Application, ANDA, Abbreviated New Drug Application, MAA, Marketing Authorization Application, eCTD, electronic Common Technical Document, CTD Modules, Module 2, Module 3, Regulatory Dossier Preparation, Variations, Supplements, Amendments, Annual Reports, Briefing Packages, Submission Publishing, FDA, Food & Drug Administration, EMA, European Medicines Agency, ICH Guidelines, Health Canada, MHRA, PMDA, WHO Guidelines, Global Regulatory Requirements, Regulatory Intelligence, Drug Substance (API), Drug Product, Formulation Development, Analytical Development, Process Development, Process Validation, Manufacturing Processes, Stability Studies, Specifications and Methods, Method Validation, Method Transfer, Comparability Studies, Impurities, Degradation Products, GMP, Good Manufacturing Practice, GxP Compliance, Quality Assurance, QA, Change Control, Deviation Management, CAPA, Corrective and Preventive Actions, Risk Assessments, Data Integrity, Audit and Inspection Readiness, Post-Approval Changes, Change Management, Veeva, Lorenz, GlobalSumit, IRB, Institutional Review Board, Clinical Trial, Clinical Research, Clinical Trial Coordinator, Regulatory Affairs Specialist, Regulatory Specialist, CMC Specialist, Regulatory Associate, Clinical Research Associate, Clinical Trial Assistant, Pharmaceutical, Pharma, Biopharmaceutical, Biotechnology, Biotech

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