Director, Regulatory Affairs CMC
CytokineticsDublin, Ireland
Posted October 1, 2025
Full Time
About the Company
Cytokinetics is a late-stage biopharmaceutical company specializing in the discovery, development, and commercialization of muscle activators and inhibitors to treat debilitating diseases affecting muscle performance. As leaders in muscle biology, they develop small molecule drugs targeting muscle function and contractility, with a focus on treating heart failure, Amyotrophic Lateral Sclerosis, and Hypertrophic Cardiomyopathy. Recognized for their innovative approach and workplace culture, Cytokinetics has been honored as a Best Place to Work multiple times.
Job Description
Cytokinetics is a late-stage specialty cardiovascular biopharmaceutical company focused on developing muscle activators and inhibitors. They are seeking a Director of Regulatory Affairs - CMC to lead regulatory support for US and international submissions, ensuring sound regulatory planning and strategic implementation of submissions.
Requirements
- Formulate CMC regulatory strategies without supervisor oversight
- Collaborate with cross-functional project teams and external business partners
- Manage the preparation and maintenance of regulatory submission documents
- Maintain knowledge and expertise with FDA/EMA regulations
- Ensure conformance to commitments made with various regulatory agencies
Benefits
- Competitive compensation
