Senior Manager, Regulatory Affairs CMC

As the Senior Manager, Regulatory Affairs CMC, you will operate as the Regulatory CMC lead for multiple programs, owning strategy and execution from early development through clinical milestones. This is a high-impact, high-ownership role for someone who thrives in a fast-moving biotech environment.

Requirements

• Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines.
• Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.).
• Own CMC regulatory deliverables end-to-end with minimal oversight.
• Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports) with a focus on timeliness, quality, and completeness.
• Identify risks early and lead teams to resolution to keep programs on track.
• Translate complex technical data into clear and concise narratives.
• Lead preparation of CMC-related responses to HA questions.
• Act as a connector and leader in discussions, not a passive participant.
• Manage multiple programs, while prioritizing effectively.
• Other duties as assigned.

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.