CMC Director/Senior Director
Talnt, Gaithersburg, MD, United States
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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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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