Senior Director, CMC Regulatory - Small Molecules

BioSpace; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Beeline Medicines in Massachusetts is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead all CMC activities from IND/CTA through NDA and post‑approval lifecycle. You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure compliant submissions and robust CMC strategies.

You will shape regulatory strategy, manage Health Authority interactions (FDA/EMA), oversee submissions in ICH CTD format, mentor teams, and

Qualifications

• Senior regulatory leadership experience in CMC for small molecules.
• Experience leading global submissions (IND/CTA through NDA).
• Strong collaboration with Development, QA, and external CMOs.

Responsibilities

• Lead CMC regulatory strategy for small molecule assets.
• Oversee global regulatory submissions in CTD/eCTD format.
• Manage Health Authority interactions (FDA/EMA).
• Coordinate with Process Development, Analytical, Manufacturing Sciences, and Quality.
• Mentor and align cross-functional teams on regulatory requirements.

Skills

CMC regulatory leadership

Regulatory strategy

FDA/EMA experience

ICH CTD

Cross-functional leadership

Tools

eCTD submissions

Job description

Beeline Medicines in Massachusetts is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead all CMC activities from IND/CTA through NDA and post‑approval lifecycle. You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure compliant submissions and robust CMC strategies.

You will shape regulatory strategy, manage Health Authority interactions (FDA/EMA), oversee submissions in ICH CTD format, mentor teams, and