Senior Director, Regulatory Affairs CMC – Small Molecule
$242,000–$313,500 year
HybridBoston, Massachusetts, United States
Job Summary
Develop and lead the CMC regulatory strategy for small molecule assets from IND/CTA through NDA filing and post-approval lifecycle management. Author, review, and oversee global regulatory submissions in ICH CTD format, including INDs, CTAs, NDAs, and variations, ensuring alignment with FDA, EMA, and Health Authority expectations. Serve as the primary regulatory authority for Technical Development, Process Chemistry, Analytical Sciences, and Quality, providing expert interpretation of ICH Q8–Q12 guidelines and advising on design space and control strategies. Lead Health Authority interactions, manage post-approval change management (SUPAC, PAS, CBE), and oversee technology transfer and CMO onboarding regulatory aspects. Establish CMC regulatory SOPs, document management workflows, and due diligence assessments for licensing or acquisition targets. Track submission timelines and risks to keep cross-functional teams aligned. Hybrid work schedule requires minimum two days on-site per week.
Required Qualifications
- Advanced degree (PhD, MS, or PharmD) in organic chemistry, pharmaceutical sciences, analytical chemistry, or a related small molecule-relevant discipline
- Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry
- Deep and comprehensive expertise in small molecule CMC regulatory strategy, including drug substance (API) synthesis and control, drug product formulation and manufacturing, and analytical method development and validation for oral, parenteral, and other dosage forms
- Extensive experience authoring and overseeing small molecule CMC sections of global regulatory submissions, including INDs/CTAs, NDAs, MAAs, and post-approval supplements and variations in ICH CTD/eCTD format
- Demonstrated track record of leading FDA and EMA CMC-focused Health Authority meetings, including preparation of briefing documents and strategic management of written responses to CMC deficiency letters
- Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12 guidelines, FDA small molecule CMC guidance documents (e.g., SUPAC, process validation, container closure), and EMA quality guidance applicable to small molecule chemical entities
- Proven experience managing CMC regulatory aspects of technology transfer, new CMO qualification, and site change regulatory filing strategies for small molecule programs
- Strong command of post-approval CMC change management regulations, including SUPAC categories, PAS/CBE filing requirements, and ex-US variation frameworks
- Demonstrated ability to lead and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment
- Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex regulatory or scientific priorities
- Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy
- Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners
- Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies
- Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations
Desired Qualifications
- Education: Advanced degree (PhD, MS, or PharmD) in organic chemistry, pharmaceutical sciences, analytical chemistry, or a related small molecule-relevant discipline strongly preferred
- Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry preferred
- Demonstrated ability to lead and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning
- Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex regulatory or scientific priorities
- Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy
- Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners
- Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies
- Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations; balances clarity, diplomacy, and scientific precision
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