Role Overview:
Cytokinetics is seeking a Director of Regulatory Affairs - CMC who leads regulatory support for assigned programs, driving US and international regulatory submission strategies with minimal supervision. Reporting to the Executive Director, they develop and implement CMC regulatory strategies, ensure timely delivery of technical documents, and manage regulatory communications and compliance.
Key Responsibilities:
- Develop CMC regulatory strategies and identify risks across cross-functional teams.
- Manage preparation, authoring, and maintenance of regulatory submissions for clinical trials, marketing applications, and post-marketing changes.
- Review CMC documentation and coordinate responses to regulatory authority queries.
- Maintain up-to-date knowledge of FDA, EMA, ICH, and international regulations.
- Provide regulatory advice and support due diligence activities.
- Build collaborative relationships internally and externally, including with vendors and health authorities.
- Possibly supervise consultants or interns and contribute to team regulatory operating guidelines.
Qualifications:
- 10-12+ years in Regulatory Affairs CMC, with 8+ years in biotech/pharma focused on small molecule drug development. Cardiovascular experience is a plus.
- Proven experience as a primary RA-CMC contact to Health Authorities with full strategic responsibility.
- Bachelor’s degree required (preferably chemistry or related), advanced degree preferred.
- Strong knowledge of international regulatory environments, GXP, eCTD, and electronic submissions.
- Excellent communication, organizational, and collaboration skills.
Job sourced from Cytokinetics.