Director, Commercial Regulatory Europe

About the role

Cytokinetics is seeking a highly experienced Director of Commercial Regulatory Affairs to lead the European MLR process and ensure all promotional activities comply with regional regulations. The role will shape the regulatory advertising and promotion infrastructure across Europe.

Key responsibilities

• Lead and manage the European MLR process, providing timely regulatory review of promotional and non‑promotional materials.
• Develop and oversee local MLR activities, including vendor selection and acting as the primary liaison between central regulatory affairs and local vendors.
• Provide training and guidance to internal teams on regulatory requirements and best practices.
• Collaborate with Commercial, Medical, Legal and Compliance teams to ensure timely, compliant regulatory activities.
• Maintain up‑to‑date knowledge of regulations, guidelines and Codes of Practice in each country and ensure SOPs are in place.

Required profile

• Minimum 8 years of experience in European regulatory affairs, advertising and promotion, with solid knowledge of EFPIA and ABPI codes.
• Proven ability to work with cross‑functional teams across EU countries.
• Strong understanding of clinical trial designs and how evidence can be used for promotional substantiation.
• Excellent communication, leadership and organizational skills.

Required skills

• Experience with electronic approval systems, preferably Veeva PromoMats.