Novartis Pharma AG
Regulatory Affairs Associate Director, CMC(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Basel
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NONovartis Pharma AG
Regulatory Affairs Associate Director, CMC(m/w/x)
Basel, Schaftenau
Full-timeWith Home OfficeExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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NONovartis Pharma AG
Regulatory Affairs Associate Director, CMC(m/w/x)
Basel, Schaftenau
Full-timeWith Home OfficeExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novartis Pharma AG
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
Noch nicht perfekt?
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