Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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RERevolution Medicines
Associate Director, Regulatory Operations, Europe(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading operational planning and execution of regulatory submissions for novel targeted therapies in oncology. 8+ years in regulatory operations, affairs, or submission management required. Preparing and publishing eCTD dossiers using Veeva Vault RIM.
Requirements
- Bachelor’s degree in life sciences or related
- 8+ years in regulatory operations, affairs, or submission management
- Experience preparing and publishing eCTD submissions
- Strong understanding of European regulatory procedures
- Hands-on experience using Veeva Vault RIM
- Hands-on experience using DocuBridge
- Ability to lead regulatory submission timelines
- Strong understanding of regulatory document management
- Proven ability to manage multiple submissions
- Strong organizational, communication, and stakeholder skills
- Familiarity with EMA IRIS platform
- Experience managing regulatory data across systems
- Experience supporting EU regulatory submissions
- Experience supporting Marketing Authorisation Applications
- Experience working in global regulatory teams
- Oncology or rare disease regulatory experience
- Experience managing regulatory publishing vendors
- Experience working in growing regulatory organization
- Experience navigating EU regulatory procedures
- Familiarity with EU regulatory data standards
Tasks
- Support European Regulatory Affairs team in executing regional strategies
- Lead operational planning and execution of regulatory submissions
- Prepare and publish regulatory dossiers to European health authorities
- Plan and execute major regulatory applications like MAAs
- Develop and manage detailed regulatory submission timelines
- Coordinate cross-functional activities for regulatory submissions
- Publish and quality control regulatory submissions in eCTD format
- Manage regulatory content and metadata in Veeva Vault RIM
- Prepare and coordinate key regulatory deliverables
- Provide operational guidance on submission requirements
- Align regional submission processes with Global Regulatory Operations
- Manage external publishing vendors and consultants
- Support global regulatory submissions as needed
- Manage regulatory procedures via EMA IRIS platform
- Ensure accuracy and consistency of structured regulatory data
- Coordinate submission activities across European channels
- Support EU regulatory lifecycle activities including variations and renewals
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- eCTD
- Veeva Vault RIM
- DocuBridge
- EMA IRIS platform
- SPOR/IDMP
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
Associate Director, Regulatory Operations, Europe(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading operational planning and execution of regulatory submissions for novel targeted therapies in oncology. 8+ years in regulatory operations, affairs, or submission management required. Preparing and publishing eCTD dossiers using Veeva Vault RIM.
Requirements
- Bachelor’s degree in life sciences or related
- 8+ years in regulatory operations, affairs, or submission management
- Experience preparing and publishing eCTD submissions
- Strong understanding of European regulatory procedures
- Hands-on experience using Veeva Vault RIM
- Hands-on experience using DocuBridge
- Ability to lead regulatory submission timelines
- Strong understanding of regulatory document management
- Proven ability to manage multiple submissions
- Strong organizational, communication, and stakeholder skills
- Familiarity with EMA IRIS platform
- Experience managing regulatory data across systems
- Experience supporting EU regulatory submissions
- Experience supporting Marketing Authorisation Applications
- Experience working in global regulatory teams
- Oncology or rare disease regulatory experience
- Experience managing regulatory publishing vendors
- Experience working in growing regulatory organization
- Experience navigating EU regulatory procedures
- Familiarity with EU regulatory data standards
Tasks
- Support European Regulatory Affairs team in executing regional strategies
- Lead operational planning and execution of regulatory submissions
- Prepare and publish regulatory dossiers to European health authorities
- Plan and execute major regulatory applications like MAAs
- Develop and manage detailed regulatory submission timelines
- Coordinate cross-functional activities for regulatory submissions
- Publish and quality control regulatory submissions in eCTD format
- Manage regulatory content and metadata in Veeva Vault RIM
- Prepare and coordinate key regulatory deliverables
- Provide operational guidance on submission requirements
- Align regional submission processes with Global Regulatory Operations
- Manage external publishing vendors and consultants
- Support global regulatory submissions as needed
- Manage regulatory procedures via EMA IRIS platform
- Ensure accuracy and consistency of structured regulatory data
- Coordinate submission activities across European channels
- Support EU regulatory lifecycle activities including variations and renewals
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- eCTD
- Veeva Vault RIM
- DocuBridge
- EMA IRIS platform
- SPOR/IDMP
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?
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