Senior Director, Biologics CMC Regulatory Strategy

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

Job summary

Beeline Medicines in the United States is seeking a Senior Director of Regulatory Affairs CMC – Biologics to lead strategic regulatory activities for large molecule therapies. You will partner with Process Development, Analytical Sciences, and Quality to shape global CMC submissions and post‑approval strategies.

You will guide interactions with FDA/EMA and drive regulatory strategy for INDs through BLA/MAA, ensuring compliance and timely milestones in a hybrid work setting.

Qualifications

• Advanced degree in biologics-related science or regulatory discipline preferred or equivalent experience.
• 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Proven track record leading FDA/EMA meetings and global submissions.
• In-depth knowledge of ICH Q8–Q13 guidelines and related regulatory frameworks.
• Experience with biologics CMC strategy, post‑approval variations, and tech transfer.

Responsibilities

• Develop and lead the CMC regulatory strategy for all biologics assets from IND/CTA through BLA and MAA filings.
• Author, review, and oversee biologics CMC sections of global regulatory submissions (INDs/CTAs, BLAs, MAAs, supplements).
• Lead regulatory interactions with FDA/EMA and other Health Authorities; provide regulatory defense and guidance.
• Oversee post‑approval CMC changes, including PACMP, PAS and EU/global variation submissions.
• Coordinate with Process Development, Analytical Sciences, Quality, and external CMOs to ensure compliant filings.

Skills

CMC regulatory strategy

Biologics expertise

FDA/EMA meetings

Global regulatory submissions

Cross-functional leadership

Regulatory guidance interpretation

Project management

Regulatory communications

Education

Advanced degree in biologics-related science or regulatory discipline

Job description

Beeline Medicines in the United States is seeking a Senior Director of Regulatory Affairs CMC – Biologics to lead strategic regulatory activities for large molecule therapies. You will partner with Process Development, Analytical Sciences, and Quality to shape global CMC submissions and post‑approval strategies.

You will guide interactions with FDA/EMA and drive regulatory strategy for INDs through BLA/MAA, ensuring compliance and timely milestones in a hybrid work setting.