Senior Director, Biologics CMC Regulatory Strategy

Beeline Medicines; Cambridge (MA); Hybride; USD 242 000 - 314 000; Plein temps

Résumé du poste

Beeline Medicines in Cambridge, MA seeks a Senior Director of Regulatory Affairs CMC – Biologics to lead global biologics CMC strategy from IND/CTA to BLA and post‑approval lifecycle.

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs to oversee submissions, health authority interactions, and regulatory strategy, shaping infrastructure for antibodies and large molecules in a fast‑paced biotech setting.

Qualifications

• 12+ years of CMC regulatory affairs experience in pharma/biotech.
• Experience authoring and overseeing biologics CMC sections of submissions (INDs/CTAs, BLAs, MAAs).
• Strong ability to lead Health Authority meetings (FDA/EMA) and regulatory strategy across lifecycle stages.

Responsabilités

• Develop and lead CMC regulatory strategy for all biologics assets from IND/CTA through BLA and post‑approval.
• Prepare biologics CMC sections of global regulatory submissions with scientific quality and defensibility.
• Lead Health Authority interactions including FDA/EMA meetings and responses to inquiries.
• Provide regulatory interpretation of ICH Q-series guidelines and guide development teams on process characterization and control strategy acceptability.
• Oversee post‑approval CMC change management and manufacturing transfers.
• Ensure submission readiness across cross‑functional teams and manage timelines.

Connaissances

CMC regulatory strategy

FDA/EMA interactions

Cross-functional leadership

ICH guidelines

Biologics expertise

Regulatory submissions

Formation

PhD/MS/PharmD in relevant biologics field

Description du poste

Beeline Medicines in Cambridge, MA seeks a Senior Director of Regulatory Affairs CMC – Biologics to lead global biologics CMC strategy from IND/CTA to BLA and post‑approval lifecycle.

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs to oversee submissions, health authority interactions, and regulatory strategy, shaping infrastructure for antibodies and large molecules in a fast‑paced biotech setting.