Senior Director, CMC Regulatory Affairs – Small Molecules

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

Benefits offered by this job

Hybrid schedule

Equity/bonus opportunity

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead global regulatory strategy for small molecule assets in the I&I portfolio. You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and CMOs to align with FDA/EMA expectations and drive submissions.

This leadership role oversees IND/CTA through NDA filings, post‑approval changes, and lifecycle management, shaping CMC programs, SOPs, and regulatory strategies

Qualifications

• Advanced degree in pharmaceutical sciences or related field is required.
• Minimum 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Strong leadership and cross-functional collaboration skills.
• Extensive experience in global regulatory submissions (IND/CTA, NDA, MAAs).
• Deep knowledge of ICH Q8/Q9/Q10/Q11/Q12 and related guidance.

Responsibilities

• Lead the CMC regulatory strategy for small molecule assets from IND/CTA through NDA and post‑approval lifecycle.
• Oversee preparation and review of CMC sections in global regulatory submissions (ICH CTD/eCTD).
• Partner with Process Development, Analytical, Manufacturing Sciences, and Quality to align regulatory plans with development goals.
• Lead Health Authority interactions (FDA/EMA) and manage responses to deficiency letters and information requests.
• Develop and maintain CMC regulatory SOPs, templates, and document management workflows.
• Track deliverables and milestones across programs to keep teams aligned and submission‑ready.

Education

Advanced degree in pharmaceutical sciences

Tools

CTD/eCTD experience

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead global regulatory strategy for small molecule assets in the I&I portfolio. You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and CMOs to align with FDA/EMA expectations and drive submissions.

This leadership role oversees IND/CTA through NDA filings, post‑approval changes, and lifecycle management, shaping CMC programs, SOPs, and regulatory strategies