Director, Commercial Regulatory Europe

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.

Cytokinetics is seeking a highly experienced Director, Commercial Regulatory Affairs, to join the Regulatory Affairs team in Europe. He/she will play a key role in ensuring that all promotional materials and activities comply with regional and local regulatory requirements, aligning with the company's commercial objectives. He/she will help develop the infrastructure of the Regulatory Affairs Advertising and Promotion in Europe, including MLR process development in EU countries where Cytokinetics is launching a product.

The ideal candidate will possess a strong experience and understanding of regulatory and Code of Practice requirements and processes related to promotion, excellent organizational skills, and the ability to work effectively with cross-functional and international teams to support business objectives.

• Advertising and promotional activities:
  Lead and manage the European MLR process, ensuring timely and compliant regulatory review of promotional and non-promotional materials in Europe.
• Training and Guidance:
  Provide training and guidance to internal teams on regulatory requirements and best practices for promotional activities and other activities as required.
• Oversight of local MLR activities:
  Develop and oversee the local MLR activities through vendor selection, management and serve as the primary liaison between the central regulatory affairs team and local regulatory vendors, ensuring alignment of regulatory strategies and objectives.
• Cross-Functional Collaboration:
  
  Work closely with internal departments, including, Commercial, Medical, Legal and Compliance teams, to ensure regulatory activities are conducted timely and compliantly.
• Regulatory Compliance:
  Ensure all Advertising and Promotion activities are conducted in compliance with applicable regulations, guidelines and Codes of Practice, maintaining up-to-date knowledge of regulatory requirements in each country’s jurisdiction.
• Standard Operations Procedures development: work cross functionally to ensure all relevant MLR SOPs at regional and local levels are in place.
• Other responsibilities may be assigned as appropriate.

• Seasoned professional with a minimum of 8 years of relevant experience with solid expertise and knowledge of the applicable European regulations, directives and guidelines, and EFPIA Code. Prior experience in advertising and promotion regulatory roles is a must, ABPI experience is of advantage.
• Must have experience dealing with cross-functional teams across the EU countries.
• Must have solid understanding of clinical trial designs and results, and how the non-clinical and clinical evidence can compliantly be used for substantiation of promotional and non-promotional claims.
• Must have experience with electronic approval systems, preferably Veeva Promo Mats
• Excellent communication abilities to effectively communicate regulatory concepts cross functionally, and excellent leadership skills.
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong interpersonal capabilities and ability to build and maintain networks.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.

The salary range for this role…