Senior Biologics CMC Regulatory Strategy Lead

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

Benefits offered by this job

Discretionary annual bonus

Long-term equity incentives

Hybrid work schedule

Job summary

Beeline Medicines is seeking a Senior Director of Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle management.

The role collaborates with Process Development, Analytical Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global authority requirements. Hybrid work with on-site days.

Qualifications

• Advanced degree or equivalent experience in biochemistry, molecular biology, pharmaceutical sciences, immunology, or related biologics discipline.
• Minimum 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Deep experience in biologics CMC regulatory strategy and up/downstream process development.

Responsibilities

• Develop and lead the CMC regulatory strategy for biologics from IND/CTA through BLA and MAAs.
• Author and oversee biologics CMC sections of global regulatory submissions (INDs/CTAs, BLAs, MAAs).
• Lead Health Authority interactions (FDA, EMA) including meetings and written responses.
• Provide regulatory interpretation of ICH Q-series and FDA/EMA guidance for large molecules.
• Manage post-approval CMC change management and site transfers.
• Oversee technology transfer activities and biosimilar comparability assessments.
• Track deliverables and maintain submission readiness across programs.

Skills

CMC regulatory strategy

Health Authority interactions

Regulatory submissions

Cross-functional leadership

Regulatory guidance

ICH CTD/eCTD knowledge

FDA/EMA meetings

Lifecycle management

Education

Advanced degree (PhD, MS, or PharmD)

Job description

Beeline Medicines is seeking a Senior Director of Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle management.

The role collaborates with Process Development, Analytical Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global authority requirements. Hybrid work with on-site days.