Director, Regulatory Affairs CMC Europe

About Cytokinetics

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.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

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 U.S. and international regulatory submission strategies.

• Formulate CMC regulatory strategies without supervisor oversight based on current regulatory intelligence.
• Collaborate with cross‑functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks, representing the department in cross‑functional project teams.
• Identify required documentation and any content quality and timeline issues for global submissions and manage the delivery of approved technical documents in accordance with project timelines.
• Manage the preparation, authoring, and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications as well as post‑marketing variations. May require technical regulatory authoring of submission package components.
• Support the evaluation of manufacturing changes for potential impact on products.
• Provide expert review of CMC documentation supporting regulatory submissions and communications.
• Coordinate preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries.
• Maintain knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines as needed to support global programs.
• Ensure conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs.
• Provide regulatory advice to other functional areas.
• May participate in regulatory due diligence activities.

• Build and maintain collaborative relationships with internal and external business partners to achieve project regulatory goals.
• Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues, and timelines.
• Develop and manage relationships with external vendors and regulatory health authorities.
• Coordinate activities for meetings and conferences with FDA, EMA, and other regulatory authorities.
• Collaborate with regulatory colleagues to provide CMC expertise as needed.

• This is an individual contributor position; however, there is the possibility for supervising consultants, contractors, and/or interns.
• Develop and implement regulatory operating guidelines and common work practices/strategies within the team.

• 10–12 years of related work experience (Director candidates typically bring 12 years; Associate level candidates may be considered with 10 years and strong potential), including 8 years in Regulatory Affairs CMC in the biotech/pharmaceutical industry; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus.
• Proven experience serving as a primary RA‑CMC contact to health authorities with full strategic responsibility.
• Bachelor’s degree required, preferably in chemistry or a closely related field; advanced degree is a plus.
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP.
• Solid working…