Biologics CMC Regulatory Strategy Lead (Hybrid)

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

Benefits offered by this job

Hybrid schedule

Discretionary bonus & equity

Job summary

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

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs, shaping global CMC submissions and health authority interactions (FDA/EMA). A proven leader with 12+ years in CMC regulatory affairs is required.

Qualifications

• Advanced degree in biochemistry, molecular biology, pharmaceutical sciences, immunology, or related field.
• 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Expertise in biologics CMC strategy, cell line development, process validation, and characterization.
• Experience leading FDA/EMA meetings and regulatory defences.
• Strong communication, strategic thinking, and cross-functional collaboration.

Responsibilities

• Lead CMC regulatory strategy for biologics assets from IND/CTA through BLA and lifecycle management.
• Author and oversee biologics CMC sections of global regulatory submissions in ICH CTD format.
• Serve as regulatory partner for Process Development, Manufacturing Sciences, Analytical, Formulation, and Quality.
• Lead Health Authority interactions (FDA/EMA) and respond to deficiency letters and info requests.
• Provide interpretation of ICH Q8–Q13 guidance and advise on comparability and control strategies.
• Manage post‑approval CMC changes, PACMP, PAS, and variation submissions across regions.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Health Authority engagement

Strategic regulatory thinking

Education

Advanced degree (PhD, MS, or PharmD)

Job description

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

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs, shaping global CMC submissions and health authority interactions (FDA/EMA). A proven leader with 12+ years in CMC regulatory affairs is required.