Revolution Medicines
Senior Director, Compliance, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
Neuer Job?Nejo!
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RERevolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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
Senior Director, Regulatory Affairs, Europe(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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.
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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- Revolution Medicines
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