Senior Director, Biologics CMC Regulatory Strategy

Beeline Medicines; Boston (MA); Hybrid; USD 242,000 - 313,500; Full time

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global regulatory standards.

As a senior leader, you will drive cross‑functional teams, influence regulatory decisions, and shape

Qualifications

• Advanced degree in biochemistry, molecular biology, pharmaceutical sciences, immunology or related biologics discipline.
• 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Experience leading FDA/EMA biologics CMC meetings and managing regulatory strategy for biologics.

Responsibilities

• Lead CMC regulatory strategy for all biologics assets through IND/CTA to BLA/MAA and lifecycle management.
• Prepare and oversee CMC sections of global regulatory submissions in ICH CTD format.
• Serve as regulatory partner for Process Development, Analytical, Manufacturing Sciences, and Quality functions on CMC topics.
• Lead Health Authority interactions (FDA/EMA) including meetings and responses to deficiency letters.
• Provide interpretation of FDA/EMA guidance and ICH Q-series relevant to large molecules.
• Oversee post-approval CMC change management strategies (PAS, PACMP, variations).
• Coordinate technology transfer activities and regulatory filing strategies for site changes and CMOs.
• Contribute to regulatory due diligence for licensing candidates or acquisitions.

Skills

CMC regulatory strategy

Biologics regulatory affairs

FDA/EMA meetings

Cross-functional leadership

ICH Q8-Q13 guidance

Regulatory strategy communication

Education

Advanced degree (PhD/MS/PharmD) in relevant field

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global regulatory standards.

As a senior leader, you will drive cross‑functional teams, influence regulatory decisions, and shape