Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
RERevolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Basel
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Developing and executing European CMC regulatory strategies for novel targeted therapies. 15+ years drug development experience, with 5+ years in EU CMC regulatory affairs, required. Support for clinical trial applications and marketing authorizations.
Anforderungen
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline
- Advanced degree (PhD, PharmD, MSc) desirable
- Minimum 15 years pharmaceutical/biotech drug development experience
- At least 5 years CMC regulatory affairs experience with European focus
- Strong expertise in EU CMC regulatory requirements
- Expertise in MAAs, variations, and lifecycle management
- Direct hands-on experience preparing/submitting regulatory documentation
- Experience supporting health agency review/approval procedures
- Experience with post approval activities
- Demonstrated experience supporting EMA submissions
- Demonstrated experience supporting EMA interactions
- Deep knowledge of EU GMP regulations
- Deep knowledge of ICH guidelines
- Ability to apply GMP and ICH guidelines across product lifecycle
- Experience with small molecules (NCEs)
- Experience managing complex CMC technical documentation
- Proven ability to lead regulatory strategy for European approvals
- Experience within global development programs
- Strong leadership skills
- Strong project management skills
- Ability to manage multiple complex programs
- Excellent communication skills
- Excellent stakeholder management skills
- Experience working cross-functionally
- Experience working with external partners
- Ability to operate effectively in a fast-paced environment
- Ability to operate effectively in a matrixed environment
- Ability to operate effectively in a global environment
Aufgaben
- Support clinical trial applications and regulatory interactions
- Ensure alignment with EU requirements and timelines
- Develop and execute European CMC regulatory strategies
- Support initial marketing authorizations and lifecycle management
- Prepare, review, and submit high-quality CMC dossiers
- Manage interactions with EMA, NCAs, and other European regulatory bodies
- Provide strategic input into global regulatory strategies
- Address EU-specific requirements and expectations
- Assess regulatory impact of CMC changes
- Provide proactive, risk-based guidance
- Interpret and apply EU regulatory requirements
- Support efficient regulatory pathways and compliance
- Monitor and communicate evolving regulatory expectations
- Anticipate regulatory risks and develop mitigation strategies
- Partner with global Regulatory Affairs, Quality, and Technical Operations
- Ensure consistent and compliant execution of submissions
- Represent CMC regulatory on cross-functional teams
- Ensure alignment between global strategy and regional execution
- Provide leadership and mentorship to team members
- Contribute to building regional CMC regulatory expertise
- Oversee external vendors and CROs
- Ensure timely, high-quality regulatory submissions and approvals
Berufserfahrung
- 15 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.
Noch nicht perfekt?
- Revolution Medicines
Senior Director, Compliance, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Senior Medical Director, Midsize Markets Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Roche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Director, Medical Operations & Project Management, Europe(m/w/x)
VollzeitRemoteSeniorBasel
RERevolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Basel
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Developing and executing European CMC regulatory strategies for novel targeted therapies. 15+ years drug development experience, with 5+ years in EU CMC regulatory affairs, required. Support for clinical trial applications and marketing authorizations.
Anforderungen
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline
- Advanced degree (PhD, PharmD, MSc) desirable
- Minimum 15 years pharmaceutical/biotech drug development experience
- At least 5 years CMC regulatory affairs experience with European focus
- Strong expertise in EU CMC regulatory requirements
- Expertise in MAAs, variations, and lifecycle management
- Direct hands-on experience preparing/submitting regulatory documentation
- Experience supporting health agency review/approval procedures
- Experience with post approval activities
- Demonstrated experience supporting EMA submissions
- Demonstrated experience supporting EMA interactions
- Deep knowledge of EU GMP regulations
- Deep knowledge of ICH guidelines
- Ability to apply GMP and ICH guidelines across product lifecycle
- Experience with small molecules (NCEs)
- Experience managing complex CMC technical documentation
- Proven ability to lead regulatory strategy for European approvals
- Experience within global development programs
- Strong leadership skills
- Strong project management skills
- Ability to manage multiple complex programs
- Excellent communication skills
- Excellent stakeholder management skills
- Experience working cross-functionally
- Experience working with external partners
- Ability to operate effectively in a fast-paced environment
- Ability to operate effectively in a matrixed environment
- Ability to operate effectively in a global environment
Aufgaben
- Support clinical trial applications and regulatory interactions
- Ensure alignment with EU requirements and timelines
- Develop and execute European CMC regulatory strategies
- Support initial marketing authorizations and lifecycle management
- Prepare, review, and submit high-quality CMC dossiers
- Manage interactions with EMA, NCAs, and other European regulatory bodies
- Provide strategic input into global regulatory strategies
- Address EU-specific requirements and expectations
- Assess regulatory impact of CMC changes
- Provide proactive, risk-based guidance
- Interpret and apply EU regulatory requirements
- Support efficient regulatory pathways and compliance
- Monitor and communicate evolving regulatory expectations
- Anticipate regulatory risks and develop mitigation strategies
- Partner with global Regulatory Affairs, Quality, and Technical Operations
- Ensure consistent and compliant execution of submissions
- Represent CMC regulatory on cross-functional teams
- Ensure alignment between global strategy and regional execution
- Provide leadership and mentorship to team members
- Contribute to building regional CMC regulatory expertise
- Oversee external vendors and CROs
- Ensure timely, high-quality regulatory submissions and approvals
Berufserfahrung
- 15 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.
Noch nicht perfekt?
- Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Senior Director, Compliance, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Senior Medical Director, Midsize Markets Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Roche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Director, Medical Operations & Project Management, Europe(m/w/x)
VollzeitRemoteSeniorBasel