Senior Director, Clinical Regulatory Affairs

Senior Director, Clinical Regulatory Affairs

Join to apply for the Senior Director, Clinical Regulatory Affairs role at Novocure

Senior Director, Clinical Regulatory Affairs

Join to apply for the Senior Director, Clinical Regulatory Affairs role at Novocure

Location : This role is based at our Global Headquarters in Baar, Switzerland . Candidates must be either currently located in the Zug area or willing to relocate.

Position Summary :

We are seeking an experienced and strategic Sr. Director of Clinical Regulatory Affairs to lead and execute global clinical regulatory strategies for our Class III medical device programs. This leadership role will be critical in supporting clinical trial design, regulatory submissions, and interactions with global health authorities (e.g., FDA, EMA, PMDA) to enable successful development and approval of cutting-edge, high-risk medical devices.

Key Responsibilities :

• Develop and lead clinical regulatory strategies for Class III medical devices from early development through market approval.
• Interpret and apply complex regulatory requirements to clinical trial planning and execution.
• Collaborate with cross-functional teams including Clinical Affairs, Quality, R&D, and Regulatory Operations.
• Author, review, and submit high-quality clinical regulatory documentation, including IDEs, PMAs, EU CTAs, and Design Dossiers.
• Ensure submissions meet the latest regulatory requirements and are completed on schedule.
• Serve as primary regulatory contact for clinical matters with global health authorities (FDA, Notified Bodies, EMA, etc.).
• Lead and prepare teams for pre-submission meetings, advisory panels, and inspections.
• Provide regulatory guidance on clinical trial protocols, informed consent forms, and investigator brochures.
• Ensure compliance with applicable clinical trial regulations (e.g., 21 CFR 812, ICH-GCP, MDR, ISO 14155).
• Lead, mentor, and develop a high-performing team.
• Actively participate in internal governance, risk assessments, and go / no-go decisions related to clinical development.

Qualifications :

Preferred Experience

Leadership Competencies

Seniority level

Seniority level

Director

Employment type

Employment type

Full-time

Job function

Job function

Legal

Industries

Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Novocure by 2x

Get notified about new Senior Director Regulatory Affairs jobs in Baar, Zug, Switzerland .

Senior Director, Regional Regulatory Affairs

Director of Regulatory Affairs International

Sr. Director Asset Regulatory Affairs Lead

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr