Senior Director, Regulatory Affairs CMC 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. Position Summary This is a permanent, full-time position based in Zug, Switzerland. The role follows a hybrid working model, with an expected presence in the Zug office three days per week and the remainder of the time working remotely from within Switzerland. Reporting to the Executive Director, Regulatory Affairs - CMC, the Senior Director, Regulatory Affairs CMC, Europe & International will serve as a spokesperson for Regulatory Affairs CMC on programs or topics of major importance.

While Europe represents the primary area of responsibility, the role may also provide regulatory leadership and support for additional international markets and global cross‑functional initiatives as business needs evolve. The individual will have full responsibility (planning and strategic implementation) for multiple programs or broad areas of significant cross‑functional impact, with a 1–3 year planning horizon.

Activities May Include Accountability for global CMC regulatory submission strategies for initial marketing applications and post‑approval life‑cycle management Effective cross‑functional collaboration with project teams and external business partners to develop CMC regulatory strategies, identify regulatory risks, and propose options for risk reduction and/or risk‑based approaches to achieve timely approvals Representing the department in cross‑functional project teams Establishing the framework for managing the preparation, authoring and maintenance of Quality‑related regulatory submission documents for global clinical trial and marketing applications, as well as post‑marketing variations Technical regulatory authoring, review, and/or approval of submissions, responses to Health Authority queries, Health Authority engagement briefing packages, and related documentation as required

Supporting regulatory impact assessments of changes applicable to clinical and/or commercial programs, considering global regulatory strategy and business impact Providing expert review and guidance to team members and cross‑functional partners in the preparation of CMC documentation supporting regulatory submissions and communications, enabling a right‑first‑time approach Maintaining knowledge and expertise of global regulations and guidance to ensure regulatory compliance is maintained, while monitoring evolving regulations, Health Authority expectations, and industry trends to enable flexible or risk‑based approaches Ensuring conformance to commitments made with regulatory agencies Providing regulatory advice to other functional areas and participating in regulatory due diligence activities as needed Relationships This person will serve as the primary Regulatory Affairs CMC lead for

Europe while also providing strategic regulatory leadership and support for additional international markets and cross‑regional initiatives as business needs evolve. The role will partner closely with US‑based colleagues and may lead or contribute to regulatory activities, submissions, process development initiatives, and Health Authority interactions across multiple regions. The successful candidate will be adept at developing and maintaining collaborative relationships with internal and external business partners, utilizing effective communication to identify, resolve, and/or elevate issues and timelines.

Management Develops, provides training on, and implements regulatory processes, procedures, and best practices within the team and cross‑functionally Qualifications Min 15+ years of related work experience, including 12+ years in Regulatory Affairs CMC within the biotech/pharmaceutical industry Min 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.

Experience in small molecule drug development and lifecycle management is required; cardiovascular therapeutic area experience is a plus Extensive experience leading the planning, preparation, and execution of CMC/Quality‑related global submissions Expertise in developing robust global CMC strategies, ensuring compliance with international regulatory requirements, and managing interactions with Health Authorities, including the FDA, EMA, and other global agencies, to secure product approvals Regulatory expertise in small molecule drug substance is a plus Proven experience serving as a primary RA‑CMC contact to Health Authorities with full strategic responsibility Experience participating in and leading Health Authority engagements for CMC/Quality‑specific and multidisciplinary meetings, including the US and EU Additional Health Authority interaction experience across Japan, China,

Canada, LATAM, APAC, and other international markets is advantageous Demonstrated success in cross‑functional collaboration, team leadership, and navigating complex CMC challenges throughout the product lifecycle while balancing business priorities Bachelor's degree required, preferably in Chemistry or a closely related scientific field; advanced degree preferred Excellent working knowledge of global regulatory requirements, industry trends, regulatory hot topics, and GxP requirements Strong understanding of core processes associated with the discovery, development, and manufacturing of small molecule products Experience with eCTD requirements and electronic submissions Experience with international regulatory submissions and processes Ability to work effectively across teams, functions, and external partners Excellent written and verbal communication skills Strong organizational skills

and attention to detail Cytokinetics is an Equal Opportunity Employer