Senior Manager, Strategic Initiatives Regulatory Affairs

Job title: Senior Manager, Strategic Initiatives Regulatory Affairs

Company: Novocure


Job description: 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 aSenior Manager, Strategic Initiatives Regulatory AffairsThe 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 . Please find more information about Novocure and our therapy on our website or by consulting our

Expected salary:

Location: Baar, Zug

Job date: Tue, 08 Jul 2025 23:01:39 GMT

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