Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
RERevolution Medicines
Associate Director, Regulatory Operations, Europe(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- eCTD
- Veeva Vault RIM
- DocuBridge
- EMA IRIS platform
- SPOR/IDMP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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RERevolution Medicines
Associate Director, Regulatory Operations, Europe(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- eCTD
- Veeva Vault RIM
- DocuBridge
- EMA IRIS platform
- SPOR/IDMP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Revolution Medicines
Branche
Pharmaceuticals
Beschreibung
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
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