Director, Regulatory Affairs

Role: Lead regulatory strategy and support for Cytokinetics' cardiovascular drug programs, ensuring compliance and successful global submissions. Responsibilities: develop and oversee regulatory plans, serve as lead on clinical study regulatory aspects, identify and mitigate regulatory risks, manage global filings, and maintain relationships with agencies and cross-functional teams. Requirements: 10+ years in drug development with at least 7+ years in regulatory affairs, preferably in small molecule drugs and cardiovascular indications; Bachelor's in a scientific discipline, advanced degrees (MD, PharmD, PhD) are a plus. HighValue: extensive experience with international regulatory requirements, GxP, eCTD submissions, and clinical trial design; leadership in regulatory teams; experience in global markets including Asia and Canada. WorkSetup: not specified; supervisory role with team management responsibilities.