Director, Regulatory Affairs CMC Europe

Das ist der Job

We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Darum lohnt es sich

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients.

Reporting to the Executive Director, Regulatory Affairs - CMC, the Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international regulatory submission strategies.

Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams.

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.

As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Responsibilities Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence.

Identifies the required documentation and any content, quality and timeline issues for global submissions and manages the deliver