Senior Director, Regulatory Affairs CMC Europe

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs - CMC, the Senior Director, Regulatory Affairs-CMC will serve as a spokesperson for Regulatory Affairs-CMC on programs or topics of major import. He/she will have full responsibility (planning and strategic implementation) for multiple programs or broad areas of significant cross-functional impact, with a 1 – 3 year planning horizon. Activities may include: - Accountability for global CMC regulatory submission strategies for initial marketing applications and post-approval life-cycle management - Effective cross-functional collaboration with project teams and external business partners to develop CMC regulatory strategies, identify regulatory risks, and propose options for risk reduction and/or risk-based approaches to achieve timely approvals - Represents the department in cross-functional project teams - Establish the framework for managing the preparati...