Senior Manager, Regulatory Affairs CMC and Devices

Role Overview

• Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs.
• Technical Authoring: Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports.
• Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone.
• Device & Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions.
• Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression.
• Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions.
• 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).
• Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation.
• Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development.
• Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations.
• Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus.
• Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.
• Meticulous attention to detail, strong 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.