Director, CMC Regulatory
About The Position
The Director, CMC Regulatory develops, drives, and executes CMC regulatory strategies for products in clinical development and seeking marketing authorization. The role combines strategic leadership with hands-on submission delivery to support global clinical trial applications, registration, commercial readiness, and lifecycle management. The Director serves as a CMC Regulatory program lead, preparing and maintaining global CMC dossiers, participating in Health Authority interactions, supporting inspection readiness and regulatory commitments, and overseeing post-approval CMC regulatory activities. The role collaborates across Regulatory Affairs, CMC, Quality, technical subject-matter experts, and external partners, while mentoring team members and improving regulatory processes and submission standards.
Requirements
- Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related scientific discipline.
- At least 15 years of experience in pharmaceutical or biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.
- Deep expertise in CMC development for new chemical entities (NCEs), with the ability to manage complex technical content.
- Experience leading global CMC-related submissions, including IND, IMPD/CTA, NDA, MAA, and post-approval variations.
- Strong knowledge of U.S. and international GMP regulations and current industry practices, with the ability to interpret and apply requirements across the product lifecycle.
- Strong project and team leadership capabilities, including prioritizing effectively, managing multiple complex programs, and fostering cross-functional collaboration.
- Effective written and verbal communication and interpersonal skills.
- Collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.
Nice To Haves
- Advanced degree (MS or Ph.D.) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field.
- Prior experience in oncology product commercialization.
Responsibilities
- Develop and execute global CMC regulatory strategies from clinical development through marketing authorization and lifecycle management, aligning regulatory activities and submission plans with program milestones and business objectives.
- Lead preparation, review, and maintenance of scientifically sound, high-quality global CMC dossiers across development stages, ensuring regulatory compliance and timely submissions.
- Participate in CMC-related Health Authority interactions, including developing meeting strategies, preparing briefing documents, and responding to Agency queries.
- Collaborate with CMC and Quality teams to support inspection readiness and fulfill regulatory commitments.
- Support post-approval CMC regulatory activities, including assessing CMC changes, determining reporting requirements and supporting data needs, and developing and executing submission strategies.
- Provide CMC regulatory assessments for change controls, deviations, and investigations, and track regulatory commitments and submission obligations.
- Collaborate with Regulatory Affairs colleagues, technical subject-matter experts, and external partners to address regional requirements, support regulatory submissions, and maintain consistency of approved CMC content.
- Mentor team members, guide regulatory resources, and contribute to improving CMC regulatory processes and submission standards.
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Significant learning and development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
