Director, Regulatory Affairs
Cytokinetics · South San Francisco, CA
RegulatoryFull-time$225k–$263kCompany career page
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Role summary
Cytokinetics seeks a Director of Regulatory Affairs to lead regulatory strategy and execution for assigned cardiovascular drug development programs. The role involves developing regulatory strategies, managing clinical study oversight, coordinating submissions, and supervising regulatory staff to support US and international approval pathways.
What they're looking for
- 10+ years drug development experience; 7+ years in regulatory affairs within biotech/pharma
- Bachelor's degree required, preferably in science; advanced degree (MD, PharmD, PhD) preferred
- Expert knowledge of international regulatory requirements, GXP, and clinical trial design
- Experience with eCTD requirements and electronic regulatory submissions
- Demonstrated management expertise with ability to lead and develop employees
- Strong cross-functional collaboration and communication skills
- Ability to manage multiple priorities in fast-paced environment
What you'll be doing
- Formulate and oversee implementation of regulatory strategies to support program objectives and drug approval
- Lead regulatory affairs activities on assigned clinical studies and provide strategic regulatory guidance to cross-functional teams
- Identify regulatory risks in development plans and develop mitigation strategies
- Coordinate preparation, submission, and management of regulatory filings and agency communications
- Supervise regulatory affairs staff, consultants, and interns; mentor department personnel
Privacy & handoff
This role links to Cytokinetics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.