Dein persönlicher KI-Karriere-Agent
Senior Manager, International Regulatory Affairs(m/w/x)
Submitting new Marketing Authorisation Applications internationally and managing post-approval lifecycle activities. Strong EU regulatory affairs experience required. Independent work in a matrixed environment, pragmatic communication.
Anforderungen
- Strong EU Regulatory Affairs experience
- Solid lifecycle management for marketed products
- Independent work in matrixed environment
- Clear, concise, pragmatic communication
- Strong relationship-building and stakeholder management
- Strong scientific background; PhD or advanced degree preferred
- International market exposure outside EU is a plus
Aufgaben
- Support regulatory strategy execution in EU and International markets
- Prepare and submit new Marketing Authorisation Applications (MAAs) internationally
- Manage post-approval lifecycle activities for marketed products
- Handle variations, renewals, and related procedures
- Collaborate with Health Authorities and global/local teams
- Build strong relationships with local partners and internal stakeholders
- Represent regional regulatory needs in global cross-functional teams
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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Senior Manager, International Regulatory Affairs(m/w/x)
Submitting new Marketing Authorisation Applications internationally and managing post-approval lifecycle activities. Strong EU regulatory affairs experience required. Independent work in a matrixed environment, pragmatic communication.
Anforderungen
- Strong EU Regulatory Affairs experience
- Solid lifecycle management for marketed products
- Independent work in matrixed environment
- Clear, concise, pragmatic communication
- Strong relationship-building and stakeholder management
- Strong scientific background; PhD or advanced degree preferred
- International market exposure outside EU is a plus
Aufgaben
- Support regulatory strategy execution in EU and International markets
- Prepare and submit new Marketing Authorisation Applications (MAAs) internationally
- Manage post-approval lifecycle activities for marketed products
- Handle variations, renewals, and related procedures
- Collaborate with Health Authorities and global/local teams
- Build strong relationships with local partners and internal stakeholders
- Represent regional regulatory needs in global cross-functional teams
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
Deciphera Pharmaceuticals
Branche
Pharmaceuticals
Beschreibung
Deciphera Pharmaceuticals is a company focused on international accounting and US GAAP reporting.
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