Biologics CMC Regulatory Lead — Hybrid, Global Strategy

Beeline Medicines; Boston; Hybrid; PHP 14,965,986 - 19,387,755; Full time

Benefits offered by this job

Hybrid work schedule

Health and wellness coverage

Paid time off

Flexible work arrangements

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead global CMC regulatory strategy for monoclonal antibodies and other large molecules. This senior role partners with Process Development, Analytical Sciences, and Quality to optimize submissions and lifecycle management.

You will oversee FDA/EMA interactions, prepare CTD submissions, manage post‑approval changes, and mentor the CMC team in a fast-paced biotech environment.

Qualifications

• Advanced degree in biologics or related field preferred or equivalent years of experience.
• 12+ years CMC regulatory affairs experience in pharma/biotech.
• Deep expertise in biologics CMC strategy and regulatory guidance.
• Proven leadership of cross-functional teams in fast-paced environments.

Responsibilities

• Lead biologics CMC regulatory strategy from IND/CTA through BLA and lifecycle management.
• Prepare and oversee biologics CMC sections of global submissions in ICH CTD format.
• Serve as regulatory partner for Process Development, Manufacturing Sciences, Analytical Development, and Quality.
• Lead FDA/EMA health authority interactions and respond to deficiency letters.
• Guide on ICH Q8/Q9/Q10/Q11/Q12/Q13 and regulation of large molecules.
• Manage post-approval CMC changes, PACMPs, PAS, and variation submissions.
• Oversee biologics technology transfer and site qualification for CMOs.

Skills

CMC strategy

Regulatory leadership

FDA meetings

Cross-functional

Education

PhD/MS/PharmD in biologics

Tools

ICH CTD/eCTD

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead global CMC regulatory strategy for monoclonal antibodies and other large molecules. This senior role partners with Process Development, Analytical Sciences, and Quality to optimize submissions and lifecycle management.

You will oversee FDA/EMA interactions, prepare CTD submissions, manage post‑approval changes, and mentor the CMC team in a fast-paced biotech environment.