Director / Senior Director, Regulatory CMC (Biologics)

We are seeking an experienced regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. The successful candidate will own the development of high-quality regulatory CMC submissions and guide cross-functional teams on phase-appropriate global regulatory expectations.

Requirements

• MS or PhD in life sciences with 10+ years of experience in a biologics focused CMC role and a minimum of 5+ years of direct regulatory CMC experience
• Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations.
• Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA etc.)

Benefits

• Competitive salary and benefits package
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work
• Opportunities for professional growth and development