Job Description

About the Role:
The CMC Director or Senior Director, Regulatory Affairs, is a strategic leadership role responsible for global Chemistry, Manufacturing, and Controls regulatory strategy and execution across the product lifecycle. This position oversees CMC submissions, regulatory intelligence, and health authority interactions to support clinical development and commercialization of biopharmaceutical products. Common search terms include Director Regulatory Affairs CMC, Senior Director CMC Regulatory, Regulatory Affairs Director Biotech, and Global CMC Lead.

Responsibilities:

• Lead global CMC regulatory strategy and execution for clinical and commercial programs, ensuring alignment with development and business objectives
• Oversee preparation, review, and submission of CMC sections for INDs, CTAs, BLAs, NDAs, and other global regulatory filings
• Manage end-to-end lifecycle of regulatory CMC activities, including submission planning, timeline development, and execution
• Provide regulatory guidance on CMC changes, assess global filing requirements, and ensure compliance with applicable regulations
• Author and review high-quality eCTD submissions, including original applications, amendments, and variations
• Lead regulatory agency interactions, including preparation of briefing documents, meeting requests, and participation in health authority meetings
• Interpret global regulatory guidelines and provide strategic regulatory intelligence to senior leadership
• Collaborate cross-functionally with CMC, Quality, Manufacturing, and Clinical teams to support regulatory deliverables
• Oversee submission of post-approval changes, supplements, and lifecycle management activities
• Drive continuous improvement of regulatory processes, SOPs, and documentation standards
• Represent regulatory affairs on program teams and provide leadership on CMC regulatory strategy and risk mitigation

Qualifications:

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related scientific discipline, with significant experience in regulatory affairs CMC within biotech or pharmaceutical industries
• 8 or more years of experience for Director level or 10 or more years for Senior Director level in regulatory CMC or related functions
• Strong expertise in global CMC regulatory requirements, including FDA, EMA, and ICH guidelines for biologics and small molecules
• Proven experience managing and authoring CMC modules within eCTD submissions for clinical and marketing applications
• Demonstrated experience leading regulatory submissions such as INDs, CTAs, NDAs, or BLAs and managing lifecycle activities
• Deep understanding of regulatory frameworks governing drugs and biologics, including post-approval changes and variations
• Strong project management skills with the ability to manage multiple programs and shifting priorities
• Excellent communication, leadership, and cross-functional collaboration skills

Desired Qualifications:

• Experience leading regulatory strategy for late-stage clinical or commercial programs
• Prior experience interacting directly with global health authorities and leading regulatory negotiations
• Familiarity with global submission platforms and regulatory information management systems
• Experience contributing to regulatory inspections, audits, and compliance activities
• Knowledge of emerging regulatory trends in CMC, including expedited pathways and global harmonization efforts

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