Senior Director, CMC Regulatory Affairs – Small Molecules

Beeline Medicines; Boston (MA); Hybrid; USD 242,000 - 314,000; Full time

Job summary

Beeline Medicines is seeking a Senior Director of Regulatory Affairs CMC for Small Molecules, responsible for strategy, execution, and regulatory leadership across IND/CTA to NDA and post-approval lifecycle. You will partner with Process Development, Analytical Sciences, Quality, and external CMOs to align on CMC programs with FDA, EMA, and global Health Authority expectations.

The role requires 12+ years in CMC regulatory affairs, deep expertise in small molecule programs, and a proven record

Qualifications

• Advanced degree preferred in organic chemistry, pharmaceutical sciences, analytical chemistry, or related, with strong small molecule focus.
• Minimum of 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Deep expertise in small molecule CMC regulatory strategy, including API synthesis, formulation, and analytics.
• Experience leading FDA/EMA meetings and regulatory submissions in ICH CTD/eCTD format.

Responsibilities

• Develop and lead CMC regulatory strategy for small molecule assets from IND/CTA through NDA and post-approval changes.
• Author and oversee CMC sections of global regulatory submissions (INDs, CTAs, NDAs, MAAs, variations).
• Lead Health Authority interactions for small molecule CMC topics (FDA/EMA meetings, responses to deficiency letters).
• Translate regulatory strategy into practical guidance for cross-functional teams (Process Development, Analytical, Manufacturing, Quality).

Skills

Regulatory leadership

CMC regulatory strategy

Cross-functional collaboration

Communication skills

Education

PhD/MS/PharmD in related field

Job description

Beeline Medicines is seeking a Senior Director of Regulatory Affairs CMC for Small Molecules, responsible for strategy, execution, and regulatory leadership across IND/CTA to NDA and post-approval lifecycle. You will partner with Process Development, Analytical Sciences, Quality, and external CMOs to align on CMC programs with FDA, EMA, and global Health Authority expectations.

The role requires 12+ years in CMC regulatory affairs, deep expertise in small molecule programs, and a proven record