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 multidiscip
Benefits
Health insuranceRemote work optionsFlexible schedule
Additional Information
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 escalate issues and timelines.
Management
This is currently an Individual Contributor position; however, there is the possibility for supervisory responsibilities in the future.
Develops, provides training on, and implements regulatory processes, procedures, and best practices within the team and cross-functionally
Cytokinetics · Zug, Switzerland