Senior Director, Regulatory Affairs Europe

Cytokinetics is seeking a highly experienced Senior Director, Regulatory Affairs Europe to join the Regulatory Affairs team in Europe. The individual will provide leadership in developing and executing best in class regulatory strategies for assigned programs in the European region. The Senior Director will lead all regulatory activities related to the submission of Marketing Authorization Applications of assigned Cytokinetics products in Europe (including UK and Switzerland) as well as implementation of post-marketing requirements.

The Senior Director, Regulatory Affairs Europe will work closely with the Global Regulatory Lead and be a member of the Global Regulatory Team. The individual will work cross-functionally including with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access and, as established country operations to ensure all regional and local regulatory requirements are met.  The individual will ensure regional and local regulatory compliance over all relevant aspects of the business in the European region. The individual will work closely with the VP, Head of Regulatory Affairs Europe, to develop the regulatory processes related to the launch of Cytokinetics commercial products in the region.

The Senior Director will also maintain awareness of the regulatory environment and communicate the impact of changes on business and product development programs. The Senior Director may deputize for the Head of Regulatory Affairs Europe as appropriate.


Responsibilities:

• Develop a robust European strategy for specific products aligning with the Global regulatory strategy and cross functionally to identify the best strategy that will lead to European approval.
• Contribute and independently execute the filing plans for Europe in line with corporate, regional and local business objectives.
• Ensure high-quality regulatory submissions are made on time and meet Cytokinetics requirements.
• Collaborate with the Regulatory Study Lead to review and provide strategic input/advice to EU CTR submissions and/or queries.
• As part of the Global Regulatory Team (GRT), provide direction and expertise on regional and local regulatory mechanisms to optimize product development.
• Provide strategic and operational contributions to EMA/national agencies interactions and their preparation.
• Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to Cytokinetics products and discuss their implications with business.
• Assesses country and regional‐specific regulations/requirements, and develops proactive regulatory plans and strategies, aligned with business goals.
• Oversees regulatory-related launch and post-marketing activities in the EU:
  • Provides regulatory input to market access strategy and HTA plans and submissions in the EU
  • Ensures local regulatory requirements are fulfilled in each country
  • Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
  • Ensures all packaging and labeling requirements are met according to local requirements
  • Ensures all post-marketing requirements and maintenance activities are met
• Work closely with the Quality department on relevant regulatory procedures applicable to the European region.

Qualifications

• Seasoned professional with a minimum of 12 years of relevant experience with a solid expertise and knowledge of the applicable European regulatory regulations, directives and guidelines.
• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred.
• Proven track record of directly leading Marketing Authorization Applications through EMA centralized procedure and national agencies (including Switzerland and UK). Experience in international markets is advantageous.
• Strong experience leading or participating in regulatory agency interactions.
• Solid foundation in science obtained through academics and business experience.
• 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.