Cytokinetics is dedicated to upholding the highest standards of excellence to bring potential medicines to patients to improve outcomes and quality of life. We are looking for Regulatory Affairs professionals who bring a strategic mindset and a deep understanding of the regulatory environment. As a member of the team, you will play a crucial role in ensuring our processes meet regulatory requirements while maintaining high standards of compliance.

Cytokinetics is seeking an experienced Director, Regulatory Affairs Europe to join the Regulatory Affairs team in Europe. He/she will provide leadership in developing and executing best in class regulatory strategies for assigned programs in the European region. The Director will lead regulatory activities related to the submission of Marketing Authorization Applications of assigned Cytokinetics products in Europe  as well as implementation of post-marketing requirements.

The Director, Regulatory Affairs Europe will work closely with the Global Regulatory Lead and be a member of the Global Regulatory Team. He/she will work cross-functionally including with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access and with country operations to ensure all regional and local regulatory requirements are met.  

The Director will also maintain awareness of the regulatory environment and communicate the impact of changes on business and product development programs.

This position offers a temporary contract till end of the year, with possibility of extension. The work set up is hybrid, with 2-3 days per week in our centrally located Zug office, and the rest of the time from home.

Responsibilities

• Develop a robust European strategy for specific products aligning with the Global regulatory strategy and cross functionally 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.
• 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 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 10 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. Fluency in English, and any other key EU market languages are an advantage.
• 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.

#LI-HYBRID

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 US and international regulatory submission strategies.

Responsibilities

• Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence.
• 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.
• Identifies the required documentation and any content, quality and timeline issues for global submissions and manages the delivery of approved technical documents in accordance with project timelines.
• Manages 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.
• Supports the evaluation of manufacturing changes for the potential impact on products.
• Provides expert review of CMC documentation supporting regulatory submissions and communications.
• Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries.
• Maintains knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.
• Ensures conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs.
• Provides regulatory advice to other functional areas.
• May participate in regulatory due diligence activities.

Relationships

• Build and maintain collaborative relationships with internal/external business partners to achieve project regulatory goals.
• Develops and maintains 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.
• Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
• Collaborate with regulatory colleagues to provide CMC expertise as needed.

Management

• This is an Individual Contributor position; however, there is the possibility for supervising consultants/contractors and/or interns.
• Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

Qualifications

• 10 - 12+ years of related work experience (Director candidates will 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 is required, preferably in chemistry or a closely related field; advanced degree is a plus.
• Advanced degree is preferred.
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Solid working knowledge of core processes associated with discovery, development, and manufacturing of small molecules.
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus.
• Ability to work effectively across teams, functions and with outside partners.
• Excellent oral and written communication skills
• Excellent organizational skills and attention to detail

#LI-HYBRID