Cytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
Full-timeFreelanceWith HomeofficeSenior
Zug
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NONovocure Inc
Senior Director, Clinical Regulatory Affairs(m/w/x)
Baar
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global clinical regulatory strategy for Tumor Treating Fields therapy. 10-12 years regulatory affairs experience with Class III medical devices required. Flexible hybrid work, trust-based model.
Requirements
- Master’s degree in life sciences, biomedical engineering, or related field
- Advanced degree preferred
- 10–12 years regulatory affairs experience
- Experience across biotech, pharma, medical device environments
- Significant experience with Class III medical devices
- At least 5 years leadership experience
- Deep expertise with IDEs, PMAs, CE Mark submissions
- Global clinical regulatory strategy for high-risk devices
- Proven experience engaging directly with FDA and global authorities
- Experience with complex clinical and regulatory matters
- Strong understanding of clinical study design
- Strong understanding of statistical principles
- Strong understanding of regulatory requirements for oncology and high-risk devices
- Ability to develop regulatory strategies
- Strategies balancing scientific, clinical, regulatory, business objectives
- Strong leadership presence
- Exceptional communication skills
- Cross-functional influencing skills
- Experience supporting oncology-focused products or therapies
- Experience in pharma, biotech, medical device, or combination products
- Deep understanding of global regulatory environments
- Understanding of FDA, EU MDR, and Asian markets
- Familiarity with software as a medical device (SaMD)
- Familiarity with combination product environments
- Experience supporting product launch preparation
- Experience supporting commercialization activities
- Experience supporting advertising, promotion, and labeling strategies
- Familiarity with digital and social media regulatory review
- Experience operating in highly matrixed, global organizations
- Experience with connected regulatory strategy, clinical evidence, commercialization readiness
Tasks
- Develop and lead global clinical regulatory strategies
- Shape regulatory approaches for clinical evidence generation
- Partner with Clinical Affairs, Medical Affairs, R&D, Marketing, Legal, Quality, and Regulatory Operations
- Provide strategic regulatory guidance for clinical study design
- Lead interactions with global health authorities
- Prepare and lead teams through regulatory engagements
- Author and review high-quality regulatory documentation
- Interpret and apply complex global regulatory requirements
- Support global product launch readiness
- Contribute to internal governance discussions
- Lead, mentor, and develop a high-performing regulatory team
Work Experience
- 10 - 12 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- IDEs
- PMAs
- CE Mark
Benefits
Flexible Working
- Flexible hybrid working model
- Trust-based working model
- Hybrid work (3 days/week in office)
- Flexible schedule
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novocure Inc and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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NONovocure Inc
Senior Director, Clinical Regulatory Affairs(m/w/x)
Baar
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global clinical regulatory strategy for Tumor Treating Fields therapy. 10-12 years regulatory affairs experience with Class III medical devices required. Flexible hybrid work, trust-based model.
Requirements
- Master’s degree in life sciences, biomedical engineering, or related field
- Advanced degree preferred
- 10–12 years regulatory affairs experience
- Experience across biotech, pharma, medical device environments
- Significant experience with Class III medical devices
- At least 5 years leadership experience
- Deep expertise with IDEs, PMAs, CE Mark submissions
- Global clinical regulatory strategy for high-risk devices
- Proven experience engaging directly with FDA and global authorities
- Experience with complex clinical and regulatory matters
- Strong understanding of clinical study design
- Strong understanding of statistical principles
- Strong understanding of regulatory requirements for oncology and high-risk devices
- Ability to develop regulatory strategies
- Strategies balancing scientific, clinical, regulatory, business objectives
- Strong leadership presence
- Exceptional communication skills
- Cross-functional influencing skills
- Experience supporting oncology-focused products or therapies
- Experience in pharma, biotech, medical device, or combination products
- Deep understanding of global regulatory environments
- Understanding of FDA, EU MDR, and Asian markets
- Familiarity with software as a medical device (SaMD)
- Familiarity with combination product environments
- Experience supporting product launch preparation
- Experience supporting commercialization activities
- Experience supporting advertising, promotion, and labeling strategies
- Familiarity with digital and social media regulatory review
- Experience operating in highly matrixed, global organizations
- Experience with connected regulatory strategy, clinical evidence, commercialization readiness
Tasks
- Develop and lead global clinical regulatory strategies
- Shape regulatory approaches for clinical evidence generation
- Partner with Clinical Affairs, Medical Affairs, R&D, Marketing, Legal, Quality, and Regulatory Operations
- Provide strategic regulatory guidance for clinical study design
- Lead interactions with global health authorities
- Prepare and lead teams through regulatory engagements
- Author and review high-quality regulatory documentation
- Interpret and apply complex global regulatory requirements
- Support global product launch readiness
- Contribute to internal governance discussions
- Lead, mentor, and develop a high-performing regulatory team
Work Experience
- 10 - 12 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- IDEs
- PMAs
- CE Mark
Benefits
Flexible Working
- Flexible hybrid working model
- Trust-based working model
- Hybrid work (3 days/week in office)
- Flexible schedule
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novocure Inc and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novocure Inc
Industry
Healthcare
Description
Das Unternehmen ist ein führender Anbieter von innovativen Therapien zur Behandlung von Krebs, insbesondere durch Tumor Treating Fields.
Not a perfect match?
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