Senior Director, Regulatory Affairs CMC – Biologics

About the role

Beeline Medicines is seeking a senior leader to provide scientific and strategic regulatory direction for Chemistry, Manufacturing, and Controls (CMC) activities across its biologics portfolio in immunology and inflammation. The Senior Director will shape CMC regulatory strategies from early development through BLA filing and post‑approval lifecycle management, acting as the company’s primary authority on biologics CMC regulatory science.

Key responsibilities

• Develop and lead CMC regulatory strategy for all biologics assets from IND/CTA through BLA/MAA filing and post‑approval variations.
• Author, review, and oversee CMC sections of global regulatory submissions in ICH CTD format, ensuring scientific quality and regulatory defensibility.
• Collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to align programs with FDA, EMA, and other health authority expectations.
• Define labeling strategy for drug substance and drug product throughout the product lifecycle.
• Contribute to cross‑functional regulatory strategy and build the company’s biologics CMC regulatory infrastructure.

Required profile

• Extensive senior‑level experience in CMC regulatory affairs for biologics, including monoclonal antibodies and large‑molecule therapeutics.
• Proven track record of leading IND/CTA, BLA, and MAA submissions and managing post‑approval lifecycle activities.
• Deep knowledge of FDA, EMA, and global health authority requirements for biologics CMC.
• Strong ability to work cross‑functionally with development, analytical, quality, and manufacturing teams.
• Demonstrated leadership in shaping regulatory strategy and infrastructure.

Required skills

• CMC regulatory strategy development
• Regulatory submission authoring (IND, CTA, BLA, MAA) in ICH CTD format
• Biologics CMC expertise (monoclonal antibodies, large‑molecule therapeutics)
• FDA and EMA regulatory knowledge
• Collaboration with Process Development, Analytical Sciences, Quality, and CMOs