Senior Director, Regulatory Affairs CMC – Small Molecule

About the role

Beeline Medicines seeks a Senior Director to provide scientific and strategic regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across its small‑molecule immunology and inflammation portfolio. The role guides CMC regulatory strategy from early clinical development through NDA filing and post‑approval lifecycle management.

Key responsibilities

• Develop and own the CMC regulatory strategy for all small‑molecule assets, covering IND/CTA, NDA, MAA, Type II variations and labeling.
• Author, review, and ensure quality of CMC sections in global regulatory submissions using ICH CTD format.
• Serve as the primary regulatory authority for Technical Development, Process Chemistry, Analytical Development, Formulation Sciences, and Quality functions.
• Partner with external CMOs to align CMC programs with FDA, EMA and other health‑authority expectations.
• Contribute to broader regulatory strategy and help shape the regulatory affairs infrastructure.

Required profile

• Senior‑level experience in small‑molecule CMC regulatory affairs within the pharmaceutical or biotech industry.
• Proven track record of leading CMC strategy from IND through NDA and post‑approval phases.
• Deep knowledge of FDA, EMA and global health‑authority requirements.
• Ability to work cross‑functionally with technical, analytical, formulation and quality teams.

Required skills

• Regulatory submissions (IND, CTA, NDA, MAA, Type II variations)
• ICH CTD format preparation
• CMC strategy development for small molecules
• FDA and EMA regulatory guidelines