CMC Regulatory Lead, Small Molecules — Equity Eligible

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

Benefits offered by this job

Annual bonus

Equity incentive

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead global CMC regulatory strategy across IND/CTA through NDA and post‑approval activities. You will collaborate with Process Chemistry, Analytical Sciences, Manufacturing, and Quality to ensure compliant submissions to FDA, EMA, and other Health Authorities.

The role requires 12+ years in CMC regulatory affairs, advanced degree in pharma sciences, and proven leadership in fast‑paced biotech

Qualifications

• Advanced degree and 12+ years of CMC regulatory affairs experience.
• Expertise in drug substance synthesis, drug product formulation, and analytics.
• Experience leading global CMC submissions and Health Authority interactions.

Responsibilities

• Lead CMC regulatory strategy for all small molecule assets from IND/CTA through NDA and post‑approval changes.
• Author and oversee CMC sections of global submissions in CTD/eCTD format.
• Serve as regulatory partner for Process Development, Analytical, Manufacturing Sciences, and Quality.
• Manage Health Authority interactions (FDA/EMA) and regulatory responses.
• Provide regulatory interpretation of ICH/Q8–Q12 guidance and advise on design space and control strategy.

Skills

CMC regulatory strategy

Health Authority communications

Cross-functional leadership

Regulatory submissions (CTD/eCTD)

Regulatory risk assessment

Education

PhD/MS/PharmD in relevant field

Tools

ICH CTD/eCTD knowledge

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead global CMC regulatory strategy across IND/CTA through NDA and post‑approval activities. You will collaborate with Process Chemistry, Analytical Sciences, Manufacturing, and Quality to ensure compliant submissions to FDA, EMA, and other Health Authorities.

The role requires 12+ years in CMC regulatory affairs, advanced degree in pharma sciences, and proven leadership in fast‑paced biotech