Senior Manager, Regulatory Affairs CMC

Role Overview

• 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.

Requirements

• Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).
• Experience as the primary CMC regulatory lead for clinical stage programs (EU CTR and ROW experience is a plus).
• Hands-on authoring experience for IND and IMPD submissions and amendments, including direct responsibility for authoring CMC sections.
• Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.
• Proven experience preparing responses to CMC health authority questions during clinical development.
• Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, and ICH.
• Strong attention to detail, organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.
• Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).

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.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.