Revolution Medicines
Director, Regulatory Affairs Labelling, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
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RERevolution Medicines
Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing regulatory pathways for Marketing Authorisation Applications in oncology. Minimum 8 years Regulatory Affairs experience required. Late-stage clinical development in a late-stage clinical oncology company.
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Anforderungen
- Degree in biological/life sciences, pharmacy, medicine, or related
- Advanced degree (PhD, PharmD, MSc) desirable
- Minimum 10 years pharmaceutical/biotech industry experience
- Minimum 8 years Regulatory Affairs experience
- Regulatory strategy role experience
- Significant oncology drug development experience preferred
- 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
- Leading internal teams on regulatory strategy
- Representing Regulatory Affairs on cross-functional teams
- Presenting to senior management
- Excellent interpersonal skills
- Excellent written communication skills
- Excellent presentation skills
- Ability to communicate complex regulatory strategies
- Thrives in fast-paced, dynamic environment
- Ability to multi-task independently
- Excellent planning and organizational skills
- Ability to work on multiple projects with tight timelines
- Excellent leadership skills
- Excellent communication skills
- Excellent stakeholder management skills
- Strong project management skills
- Strong organizational skills
Aufgaben
- Develop, plan, and execute regulatory pathways for Marketing Authorisation Applications
- Manage lifecycle management activities in the European Region
- Develop and execute European regulatory strategies for Marketing Authorisation Applications
- Lead regional regulatory planning and oversee integrated filing plans
- Define timelines, deliverables, and critical path activities for filings
- Collaborate with Global Regulatory Team on filing plans
- Direct and coordinate Marketing Authorisation Application submissions
- Ensure dossier readiness for submissions
- Align cross-functional teams for submissions
- Obtain management endorsement for submissions
- Serve as the primary regulatory liaison with European health authorities
- Lead interactions and communications with EMA and EU/EEA national agencies
- Lead preparation and review of Scientific Advice Briefing Packages
- Lead preparation and review of Orphan Designation Applications
- Lead preparation and review of Paediatric Investigation Plans
- Identify, assess, and mitigate regulatory risks impacting timelines or outcomes
- Communicate progress and risks to senior leadership
- Partner with global regulatory leads to ensure alignment between global and regional strategies
- Act as a strategic partner to cross-functional teams
- Ensure compliance with European regulatory requirements
- Ensure compliance with European pharmacovigilance requirements
- Ensure compliance with European governance requirements
- Monitor and interpret evolving European regulatory requirements
- Monitor and interpret evolving European regulatory guidelines
- Monitor and interpret evolving European regulatory trends
- Communicate the impact of regulatory changes across functions
- Oversee external vendors for regulatory submissions
- Oversee CROs for regulatory submissions
- Ensure timely, high-quality regulatory submissions and approvals
Berufserfahrung
8 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Von Nejo automatisch aufbereitet
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.
Zur Originalanzeige bei Revolution MedicinesÜber das Unternehmen
RE
PharmaceuticalsBasel
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
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