Senior Director, Regulatory Affairs CMC – Small Molecule

Job Summary:

The Senior Director, Regulatory Affairs CMC – Small Molecules provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's small molecule assets within the immunology and inflammation (I&I) portfolio. This role is responsible for developing and executing CMC regulatory strategies from early clinical development through NDA filing and post-approval lifecycle management, serving as the company's foremost authority on small molecule CMC regulatory science. The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure that CMC programs are designed, documented, and submitted in full alignment with FDA, EMA, and global Health Authority expectations. As a senior leader within the Regulatory Affairs organization, this individual also contributes to the broader regulatory strategy, and plays a key role in shaping the company's regulatory affairs infrastructure

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Develop and lead the CMC regulatory strategy for all small molecule assets in the I&I portfolio, from IND/CTA through NDA filing, including post-approval lifecycle management and labeling strategy for drug substance and drug product.
• Author, review, and oversee the preparation of CMC sections of global regulatory submissions in ICH CTD format, including INDs, CTAs, NDAs, MAAs, Type II variations, and supplements, with accountability for quality, completeness, and regulatory defensibility.
• Serve as the company's primary regulatory authority and strategic partner for small molecule Technical Development, Process Chemistry, Analytical Development, Formulation Sciences, and Quality functions on all CMC regulatory matters.
• Lead Health Authority interactions related to small molecule CMC topics, including FDA Type B and Type C meetings, EMA Scientific Advice meetings, and written responses to CMC deficiency letters and information requests from global regulatory agencies.
• Provide expert regulatory interpretation of FDA, EMA, and ICH CMC guidance documents applicable to small molecules, including ICH Q8, Q9, Q10, Q11, and Q12, and proactively advise development teams on design space, process validation, and control strategy regulatory acceptability.
• Lead post-approval CMC change management strategy for small molecule programs, including SUPAC assessments, Prior Approval Supplements (PAS), Changes Being Effected (CBE) filings, and ex-US variation submissions.
• Oversee regulatory aspects of small molecule technology transfer activities, including new CMO onboarding, site-to-site comparability, and associated regulatory filing updates.
• Establish and maintain CMC regulatory SOPs, templates, and document management workflows specific to small molecule programs, ensuring compliance with ICH CTD, eCTD, and applicable electronic submission requirements.
• Contribute to regulatory due diligence evaluations of small molecule licensing candidates or acquisition targets, providing CMC regulatory risk assessment and readiness analysis.
• Tracks CMC regulatory deliverables and submission timelines across all small molecule programs, ensuring proactive identification of dependencies, risks, and upcoming milestones to keep cross-functional teams aligned and submission-ready.
• Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence.
• Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.
• Perform other duties and responsibilities as assigned

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
• 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; 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