[Hiring] Senior Director, Regulatory Affairs CMC @Beeline Medicines

Role Description

The Senior Director, Regulatory Affairs CMC provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's 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.

• 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.
• Track 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.
• 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.
• Hands-on small molecule CMC regulatory experience is required.
• 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, 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.
• Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams.
• Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations.

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country).
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements.
• Flexible work arrangements / hybrid schedule.
• Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.