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Why Novocure?
At Novocure, we are revolutionizing cancer care with Tumor Treating Fields (TTFields) therapy, a cutting edge, non-invasive approach that’s changing lives. Our mission is clear: together with our patients we strive to extend survival in some of the most aggressive forms of cancer. We’re a company with the drive of a startup and the strength of 25 years of success.
Join us in shaping the future of oncology and making a real impact—because every breakthrough begins with courageous thinking.
To support our team in Baar, Switzerland we are looking for a
Senior Manager, Strategic Initiatives Regulatory Affairs
The Senior Manager, Strategic Initiatives Regulatory Affairs plays a pivotal role in shaping and executing the long-term regulatory strategy for our medical device portfolio. This position drives cross-functional regulatory programs that enhance global compliance readiness, support innovation, and optimize regulatory systems and operations. The ideal candidate has a proven track record of translating strategy into executionis with a strategic mindset, strong leadership skills, and a deep understanding of how to incorporate market research and competitive analysis into key differentiators/ value propositions in a regulated market.
Your responsibilities:
Strategic Program Management
- Lead high-impact regulatory initiatives aligned with business and regulatory strategy, including regulatory transformation, global expansion, and innovation enablement.
- Partner with senior leaders to prioritize and deliver initiatives that strengthen regulatory infrastructure and future-readiness.
Regulatory Foresight & Planning
- Be able to work with Regulatory Intelligence to proactively monitor and interpret evolving regulatory trends and changes (e.g., FDA, EU MDR, Health Canada, PMDA).
- Translate complex regulatory intelligence into strategic plans that inform product and business decision-making.
Operational Excellence
- Drive improvements to regulatory systems, SOPs, templates, and tools to increase efficiency, scalability, and compliance.
- Establish frameworks for knowledge management, risk mitigation, and decision governance within the regulatory function.
Cross-functional Leadership
- Facilitate collaboration across Regulatory Affairs, Clinical, Quality, R&D, Legal, and Commercial teams to ensure integrated strategies with multi-functional input and .
- Serve as a strategic advisor during product development, design changes, lifecycle management, and geographic expansion.
- Influence product positioning and messaging across the pipeline and portfolio by integrating regulatory requirements early for commercial initiatives.
Capability Development
- Mentor and support team members and stakeholders on regulatory best practices, frameworks, and strategic planning tools.
- Lead internal training programs and readiness efforts related to new regulations and key initiatives.
Metrics and Performance Reporting
- Develop KPIs to track initiative success and provide executive-level reporting on progress, risks, and outcomes.
- Support budget planning and resource allocation tied to strategic projects.
Your Profile:
- Bachelor’s degree in a scientific, engineering, or regulatory field (Master’s, PhD, or JD preferred)
- 7-10+ years of experience in regulatory affairs within the medical device industry, including strategic or global initiatives
- Proven experience managing complex, cross-functional regulatory projects or programs
- Excellent leadership, communication, and influencing skills at all organizational levels
- Highly organized with strong analytical, problem-solving, and strategic thinking abilities
- Experience with Class II/III devices, digital health, or software as a medical device (SaMD) is preferred
- Familiarity with strategic business planning, operational transformation, or M&A regulatory integration is preferred
We are looking forward to receive your application to Natalia Munchow, Senior Talent Partner through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.