Senior Director, Regulatory Affairs CMC – Biologics

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 – Biologics provides senior‑level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's biologics assets within the immunology and inflammation (I&I) portfolio, including monoclonal antibodies and other large molecule therapeutic modalities. This role is responsible for developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing and post‑approval lifecycle management, serving as the company's foremost authority on biologics CMC regulatory science.

The Senior Director collaborates closely with Process Development, Analytical Sciences, Quality, and external biologics CMOs to ensure that programs are developed, characterized, and submitted in alignment with FDA, EMA, and global Health Authority expectations for biological products. As a senior leader within the Regulatory Affairs organization, this individual also contributes to cross‑functional regulatory strategy and plays a foundational role in shaping the company's biologics CMC regulatory 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 biologics assets in the I&I portfolio, from IND/CTA through BLA and MAA filing, including post‑approval lifecycle management and labeling strategy for drug substance and drug product.
• Author, review, and oversee the preparation of biologics CMC sections of global regulatory submissions in ICH CTD format, including INDs/CTAs, BLAs, MAAs, supplements, and post‑approval variations, with accountability for scientific quality, completeness, and regulatory defensibility.
• Serve as the company's primary regulatory authority and strategic partner for biologics Process Development, Upstream and Downstream Manufacturing Sciences, Analytical Development, Formulation, and Quality functions on all CMC regulatory matters.
• Lead Health Authority interactions related to biologics CMC topics, including FDA Type B and Type C meetings (including BPD 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 and EMA biologics CMC guidance documents and ICH Q‑series guidelines applicable to large molecules, including ICH Q8, Q9, Q10, Q11, Q12, and Q13, and advise development teams on process characterization, comparability, and control strategy regulatory acceptability.
• Lead post‑approval CMC change management strategy for biologics programs, including PACMP development, Prior Approval Supplements (PAS), CBE filings, and EU/global variation submissions related to manufacturing process changes, site changes, and analytical method updates.
• Oversee regulatory aspects of biologics technology transfer activities, including biosimilar comparability assessments, new CMO site qualification, and regulatory filing strategies for site‑to‑site manufacturing…