Biologics CMC Regulatory Senior Director – Hybrid

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

Job summary

Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across Process Development, Analytical Sciences, and Quality to ensure regulatory compliance from IND/CTA through post‑approval lifecycle.

The role demands 12+ years of CMC regulatory experience, advanced education in a

Qualifications

• Advanced degree in a biologics-related discipline strongly preferred.
• 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Extensive experience authoring INDs/CTAs, BLAs, MAAs and post‑approval variations.
• Experience leading FDA and EMA biologics CMC meetings (e.g., BPD, pre‑BLA).
• Proven ability to lead cross‑functional teams and influence stakeholders.

Responsibilities

• Develop and lead the CMC regulatory strategy for biologics across lifecycle (IND/CTA through BLA/MAA).
• Prepare and oversee biologics CMC sections of global submissions in ICH CTD format.
• Serve as regulatory authority partner for Process Development, Manufacturing Sciences, Analytical Development, Formulation and Quality.
• Lead Health Authority interactions related to CMC topics and respond to deficiency letters.
• Provide regulatory interpretation of ICH Q8/Q9/Q10/Q11/Q12/Q13 and guide process characterization, comparability, and control strategy regulatory acceptability.
• Oversee post‑approval CMC change management and variation submissions (PAS, PACMP, CBE).
• Manage biologics technology transfer and CMO site qualification regulatory strategies.
• Contribute to regulatory due diligence on licensing candidates or acquisitions.

Skills

Regulatory strategy

CMC regulatory submissions

FDA/EMA meetings

Cross-functional leadership

Project management

Education

Advanced degree in biologics-related field

Job description

Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across Process Development, Analytical Sciences, and Quality to ensure regulatory compliance from IND/CTA through post‑approval lifecycle.

The role demands 12+ years of CMC regulatory experience, advanced education in a