Dein persönlicher KI-Karriere-Agent
Regulatory Affairs Associate Director, CMC(m/w/x)
Global CMC regulatory strategy development and submission coordination. Strong CMC regulatory understanding and scientific data evaluation skills required. 4-day work week, 6 weeks vacation.
Anforderungen
- English fluency (written and spoken)
- Scientific degree or equivalent experience
- CMC Regulatory Affairs capability
- Strong CMC regulatory understanding
- Scientific data evaluation skills
- Pharmaceutical development knowledge
- Cross-functional team collaboration
- Planning and organisational skills
Aufgaben
- Develop and implement global CMC regulatory strategies
- Support regulatory activities across development and lifecycle stages
- Plan and coordinate CMC submission activities
- Author and review CMC regulatory documentation
- Identify documentation requirements and manage content alignment
- Ensure high-quality submission content and compliance
- Communicate regulatory risks and updates to project teams
- Prepare and support Health Authority interactions
- Collaborate across functions for consistent delivery
- Contribute to continuous improvement initiatives
- Support knowledge sharing within the regulatory community
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
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Regulatory Affairs Associate Director, CMC(m/w/x)
Global CMC regulatory strategy development and submission coordination. Strong CMC regulatory understanding and scientific data evaluation skills required. 4-day work week, 6 weeks vacation.
Anforderungen
- English fluency (written and spoken)
- Scientific degree or equivalent experience
- CMC Regulatory Affairs capability
- Strong CMC regulatory understanding
- Scientific data evaluation skills
- Pharmaceutical development knowledge
- Cross-functional team collaboration
- Planning and organisational skills
Aufgaben
- Develop and implement global CMC regulatory strategies
- Support regulatory activities across development and lifecycle stages
- Plan and coordinate CMC submission activities
- Author and review CMC regulatory documentation
- Identify documentation requirements and manage content alignment
- Ensure high-quality submission content and compliance
- Communicate regulatory risks and updates to project teams
- Prepare and support Health Authority interactions
- Collaborate across functions for consistent delivery
- Contribute to continuous improvement initiatives
- Support knowledge sharing within the regulatory community
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Novartis Pharma AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
Noch nicht perfekt?
- Novartis Pharma AG
Regulatory Affairs Associate Director, CMC(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBasel - Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Novartis Pharma AG
Global Regulatory Affairs Director (Neuroscience)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Boehringer Ingelheim
Regulatory Affairs Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBasel - Revolution Medicines
Associate Director, Regulatory Operations, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel