Senior Director, Regulatory Affairs CMC – Small Molecule

About Beeline Medicines:
Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact.

Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

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.

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.

• 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, TypeII 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 TypeB and TypeC 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 ICHQ8, 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 ICHCTD, eCTD, and applicable electronic submission requirements.
• Contribute to regulatory due diligence evaluations of small molecule licensing candidates or…