Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Full-timeWith HomeofficeManagement
Basel
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RERevolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading EU, EEA, UK, and Switzerland regulatory strategy for novel oncology therapies. Deep understanding of European regulatory frameworks required. Primary contact for European regulatory agencies.
Requirements
- Degree in biological/life sciences, pharmacy, or medicine
- Advanced degree (PhD, PharmD, MSc) desirable
- Significant oncology drug development experience
- Significant checkpoint inhibitors experience
- Deep understanding of European regulatory frameworks
- Deep understanding of oncology guidelines
- Success in EMA/MHRA submissions and approvals
- MAA, Paediatric, Orphan Designations experience
- Hands-on experience preparing/submitting regulatory documentation
- Experience with post approval activities
- Experience interacting with EMA and European agencies
- Experience in strategic problem-solving with health agencies
- Experience leading internal teams on regulatory strategy
- Experience representing Regulatory Affairs on cross-functional teams
- Experience presenting to senior management
- Excellent interpersonal skills
- Excellent written skills
- Excellent presentation skills
- Ability to communicate complex regulatory strategies
- Thrives in fast-paced, dynamic environment
- Ability to multi-task independently
- Limited supervision
- Excellent planning skills
- Excellent organizational skills
- Ability to work simultaneously on multiple projects
- Ability to work with tight timelines
- Excellent leadership skills
- Excellent communication skills
- Excellent stakeholder management skills
- Strong project management skills
- Strong organizational skills
Tasks
- Lead regional regulatory strategy for EU, EEA, UK, and Switzerland
- Develop and execute regulatory pathways for Marketing Authorisation Applications
- Manage lifecycle management activities in the European Region
- Ensure regulatory submissions meet requirements and timelines
- Serve as primary contact for European regulatory agencies
- Prepare and review Scientific Advice Briefing Packages
- Handle Orphan Designation Applications and Paediatric Plans
- Lead EMA, Rapporteur, and Oral Explanations interactions
- Provide regional regulatory input to clinical trial design
- Contribute to labelling strategy and post-marketing activities
- Align global and regional regulatory strategies
- Integrate regional insights into disease area and product strategies
- Partner with R&D, medical affairs, safety, market access, and commercial teams
- Ensure compliance with regulatory and pharmacovigilance requirements
- Identify and communicate European regulatory trends and impacts
- Oversee work with outside vendors and CROs
- Provide managerial leadership to direct reports
- Prioritize resources to achieve corporate and regional goals
- Coach and mentor direct reports
- Ensure staff compliance with corporate and departmental policies
Work Experience
- 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Revolution Medicines 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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RERevolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading EU, EEA, UK, and Switzerland regulatory strategy for novel oncology therapies. Deep understanding of European regulatory frameworks required. Primary contact for European regulatory agencies.
Requirements
- Degree in biological/life sciences, pharmacy, or medicine
- Advanced degree (PhD, PharmD, MSc) desirable
- Significant oncology drug development experience
- Significant checkpoint inhibitors experience
- Deep understanding of European regulatory frameworks
- Deep understanding of oncology guidelines
- Success in EMA/MHRA submissions and approvals
- MAA, Paediatric, Orphan Designations experience
- Hands-on experience preparing/submitting regulatory documentation
- Experience with post approval activities
- Experience interacting with EMA and European agencies
- Experience in strategic problem-solving with health agencies
- Experience leading internal teams on regulatory strategy
- Experience representing Regulatory Affairs on cross-functional teams
- Experience presenting to senior management
- Excellent interpersonal skills
- Excellent written skills
- Excellent presentation skills
- Ability to communicate complex regulatory strategies
- Thrives in fast-paced, dynamic environment
- Ability to multi-task independently
- Limited supervision
- Excellent planning skills
- Excellent organizational skills
- Ability to work simultaneously on multiple projects
- Ability to work with tight timelines
- Excellent leadership skills
- Excellent communication skills
- Excellent stakeholder management skills
- Strong project management skills
- Strong organizational skills
Tasks
- Lead regional regulatory strategy for EU, EEA, UK, and Switzerland
- Develop and execute regulatory pathways for Marketing Authorisation Applications
- Manage lifecycle management activities in the European Region
- Ensure regulatory submissions meet requirements and timelines
- Serve as primary contact for European regulatory agencies
- Prepare and review Scientific Advice Briefing Packages
- Handle Orphan Designation Applications and Paediatric Plans
- Lead EMA, Rapporteur, and Oral Explanations interactions
- Provide regional regulatory input to clinical trial design
- Contribute to labelling strategy and post-marketing activities
- Align global and regional regulatory strategies
- Integrate regional insights into disease area and product strategies
- Partner with R&D, medical affairs, safety, market access, and commercial teams
- Ensure compliance with regulatory and pharmacovigilance requirements
- Identify and communicate European regulatory trends and impacts
- Oversee work with outside vendors and CROs
- Provide managerial leadership to direct reports
- Prioritize resources to achieve corporate and regional goals
- Coach and mentor direct reports
- Ensure staff compliance with corporate and departmental policies
Work Experience
- 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Revolution Medicines 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
Revolution Medicines
Industry
Pharmaceuticals
Description
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
Not a perfect match?
- Revolution Medicines
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Full-timeWith HomeofficeSeniorBaselfrom CHF 241,900 - 302,400 / year - Revolution Medicines
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