Revolution Medicines
Senior Director, Compliance(m/w/x)
Full-timeRemoteSenior
Basel
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RERevolution Medicines
Senior Director, Regulatory Affairs(m/w/x)
Basel
from USD 80,000 - 100,000 / year
Full-timeRemoteSenior
Nejo AI Summary
Leading EU regulatory strategy for novel oncology therapies. Oncology drug development and EU regulations understanding required. Unlimited PTO, 401k matching.
Requirements
- Thorough understanding of oncology drug development
- Understanding of applicable European regulations
- Driving proactive engagement with health authorities
- Degree in biological or life sciences
- Degree in pharmacy
- Degree in medicine
- Degree in related fields
- Advanced degree (PhD, PharmD, MSc) is desirable
- Significant experience with oncology drug development
- Significant experience with checkpoint inhibitors highly preferred
- Deep understanding of European regulatory frameworks
- Deep understanding of oncology guidelines
- Demonstrated success in EMA/MHRA submissions and approvals
- MAA experience
- Paediatric experience
- Orphan Designations experience
- Direct hands-on experience in preparation of regulatory documentation
- Direct hands-on experience in submission of regulatory documentation
- Experience in post approval activities
- Experience interacting with EMA
- Experience interacting with other European agencies
- Demonstrated experience in strategic problem-solving with health agencies
- Leading internal teams on regulatory strategy
- Experience representing Regulatory Affairs on cross-functional teams
- Presenting to senior management
- Excellent interpersonal skills
- Excellent written skills
- Excellent presentation skills
- Ability to effectively 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
- Tight timelines
- Excellent leadership skills
- Excellent communication skills
- Excellent stakeholder management skills
- Strong project management skills
- Strong organizational skills
Tasks
- Lead regional regulatory strategy development and execution
- 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 agency interactions
- Lead Scientific Advice Briefing Package preparation
- Lead Orphan Designation Application preparation
- Lead Paediatric Plan preparation
- Lead EMA interactions and Oral Explanations
- Provide regional regulatory input to clinical trial design
- Provide regional regulatory input to labelling strategy
- Provide regional regulatory input to post-marketing activities
- Partner with global regulatory leads for strategy alignment
- Incorporate regional insights into product strategies
- Act as strategic partner to global and regional teams
- Ensure compliance with regulatory requirements
- Communicate impact of European regulatory trends
- Oversee vendor and CRO work for submissions
- Provide managerial leadership to direct reports
- Coach and mentor direct reports
- Ensure staff compliance with policies
Work Experience
- 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EMA
- MHRA
- Swissmedic
- MAA
- Paediatric
- Orphan Designations
Benefits
Healthcare & Fitness
- Health insurance
Retirement Plans
- 401k matching
More Vacation Days
- Unlimited PTO
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(m/w/x)
Basel
from USD 80,000 - 100,000 / year
Full-timeRemoteSenior
Nejo AI Summary
Leading EU regulatory strategy for novel oncology therapies. Oncology drug development and EU regulations understanding required. Unlimited PTO, 401k matching.
Requirements
- Thorough understanding of oncology drug development
- Understanding of applicable European regulations
- Driving proactive engagement with health authorities
- Degree in biological or life sciences
- Degree in pharmacy
- Degree in medicine
- Degree in related fields
- Advanced degree (PhD, PharmD, MSc) is desirable
- Significant experience with oncology drug development
- Significant experience with checkpoint inhibitors highly preferred
- Deep understanding of European regulatory frameworks
- Deep understanding of oncology guidelines
- Demonstrated success in EMA/MHRA submissions and approvals
- MAA experience
- Paediatric experience
- Orphan Designations experience
- Direct hands-on experience in preparation of regulatory documentation
- Direct hands-on experience in submission of regulatory documentation
- Experience in post approval activities
- Experience interacting with EMA
- Experience interacting with other European agencies
- Demonstrated experience in strategic problem-solving with health agencies
- Leading internal teams on regulatory strategy
- Experience representing Regulatory Affairs on cross-functional teams
- Presenting to senior management
- Excellent interpersonal skills
- Excellent written skills
- Excellent presentation skills
- Ability to effectively 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
- Tight timelines
- Excellent leadership skills
- Excellent communication skills
- Excellent stakeholder management skills
- Strong project management skills
- Strong organizational skills
Tasks
- Lead regional regulatory strategy development and execution
- 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 agency interactions
- Lead Scientific Advice Briefing Package preparation
- Lead Orphan Designation Application preparation
- Lead Paediatric Plan preparation
- Lead EMA interactions and Oral Explanations
- Provide regional regulatory input to clinical trial design
- Provide regional regulatory input to labelling strategy
- Provide regional regulatory input to post-marketing activities
- Partner with global regulatory leads for strategy alignment
- Incorporate regional insights into product strategies
- Act as strategic partner to global and regional teams
- Ensure compliance with regulatory requirements
- Communicate impact of European regulatory trends
- Oversee vendor and CRO work for submissions
- Provide managerial leadership to direct reports
- Coach and mentor direct reports
- Ensure staff compliance with policies
Work Experience
- 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EMA
- MHRA
- Swissmedic
- MAA
- Paediatric
- Orphan Designations
Benefits
Healthcare & Fitness
- Health insurance
Retirement Plans
- 401k matching
More Vacation Days
- Unlimited PTO
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.
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.
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