Senior Manager, CMC Regulatory Affairs

Key Responsibilities

• Support the development and execution of global CMC regulatory strategies for clinical development programs and initial marketing applications, in alignment with business objectives and regulatory requirements.
• Lead post-approval CMC regulatory lifecycle management activities, including strategy development and execution for variations, supplements, renewals, annual reports, and other post-approval submissions.
• Prepare, review, compile, maintain, and submit CMC regulatory dossiers (Modules 2.3 and 3) and related documentation for clinical and commercial products, including INDs, IMPDs, CTAs, NDAs, MAAs, amendments, and lifecycle management submissions.
• Support the preparation and coordination of responses to health authority questions, deficiency letters, requests for information, and regulatory commitments.
• Collaborate with cross-functional teams to support regulatory assessments and filing strategies for manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain changes.
• Maintain regulatory documentation systems and repositories, ensuring version control, traceability, inspection readiness, and compliance.
• Perform change control assessments and regulatory impact evaluations to determine appropriate filing strategies and reporting requirements globally.
• Support continuous improvement of regulatory processes, documentation standards, templates, and submission workflows.
• Serve as a CMC regulatory representative on cross-functional project teams.

Requirements

• Bachelor's degree in a scientific discipline, Chemistry and advanced degree preferred.
• 8 years in the pharmaceutical industry, with a minimum of 6 years in Regulatory.
• Proven experience supporting CMC regulatory submissions, including INDs, IMPDs, CTAs, NDAs, MAAs, ANDAs, and post-approval lifecycle management activities.
• Experience supporting global regulatory filings and interactions with health authorities, including FDA, EMA, and other international regulatory agencies.
• Strong knowledge of FDA regulations, ICH guidelines, and global regulatory requirements related to pharmaceutical development, registration, change control, and post-approval reporting.
• Solid understanding of GxP standards, quality systems, policies, and procedures.
• Experience supporting regulatory assessment of manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain changes.
• Experience and understanding of drug substance and drug product development, manufacturing processes, analytical testing, and control strategies; experience with small molecules preferred.
• Experience working with CMOs, CDMOs, and external regulatory partners.
• Experience with electronic document management systems, submission platforms, and regulatory information management tools.
• Excellent verbal, written, and interpersonal communication skills.
• Strong project management and organizational skills.
• Collaborative problem-solver with the ability to assess regulatory risks and develop practical solutions.
• Able to work independently and effectively within cross-functional and global teams.
• Experience supporting regulatory inspections, audits, due diligence activities, and health authority interactions is preferred.
• Able to travel domestically and internationally, as required (approximately 5–10%).