Merz Therapeutics
Regulatory CMC Writing Manager(m/w/x)
Full-timeWith HomeofficeManagement
Frankfurt am Main
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SASanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Evaluating manufacturing procedures for regulatory compliance of cardiovascular medicines. 1-5 years direct Regulatory CMC experience preferred. Flexible working time models.
Requirements
- Desirable technical pharmaceutical CMC experience
- Preferred 1-5 years direct Regulatory CMC experience
- Knowledge of global regulations and guidelines
- Strategic thinking for technical and regulatory issues
- Initiative, independent thinking, and anticipatory foresight
- Effective communication to internal and external audiences
- Ability to make decisions in moving environments
- Knowledge of Chemical and Biological products
- Skills for internal data management systems
- Ph.D, Master in science/health, or equivalent
- Fluency in German and English language
Tasks
- Assess manufacturing and control procedures for regulatory compliance
- Evaluate and decide on the regulatory impact of product changes
- Organize site meetings to manage regulatory activities
- Participate in global meetings regarding regulatory changes
- Communicate regulatory timelines and approval statuses to QA functions
- Provide regulatory expertise for new product introductions and technologies
- Advise on change management for transfer projects
- Write submission-ready CMC documents using optimized terminology
- Support worldwide marketing authorizations and site registrations
- Collect GMP-related documents from manufacturing sites
- Coordinate regulatory requests following dossier variations
- Prepare answers for Health Authority inquiries with site experts
- Act as the interface between Global Regulatory Affairs and manufacturing
- Collaborate on standard operating procedures with regulatory context
- Support continuous improvement of regulatory working processes
- Prepare for and participate in inspections as a subject matter expert
- Optimize the use of company software for regulatory management
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- internal data management systems
- documentation tools
Benefits
Modern Office
- Modern working environment
Flexible Working
- Hybrid working models
- Flexible working time models
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH 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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SASanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Evaluating manufacturing procedures for regulatory compliance of cardiovascular medicines. 1-5 years direct Regulatory CMC experience preferred. Flexible working time models.
Requirements
- Desirable technical pharmaceutical CMC experience
- Preferred 1-5 years direct Regulatory CMC experience
- Knowledge of global regulations and guidelines
- Strategic thinking for technical and regulatory issues
- Initiative, independent thinking, and anticipatory foresight
- Effective communication to internal and external audiences
- Ability to make decisions in moving environments
- Knowledge of Chemical and Biological products
- Skills for internal data management systems
- Ph.D, Master in science/health, or equivalent
- Fluency in German and English language
Tasks
- Assess manufacturing and control procedures for regulatory compliance
- Evaluate and decide on the regulatory impact of product changes
- Organize site meetings to manage regulatory activities
- Participate in global meetings regarding regulatory changes
- Communicate regulatory timelines and approval statuses to QA functions
- Provide regulatory expertise for new product introductions and technologies
- Advise on change management for transfer projects
- Write submission-ready CMC documents using optimized terminology
- Support worldwide marketing authorizations and site registrations
- Collect GMP-related documents from manufacturing sites
- Coordinate regulatory requests following dossier variations
- Prepare answers for Health Authority inquiries with site experts
- Act as the interface between Global Regulatory Affairs and manufacturing
- Collaborate on standard operating procedures with regulatory context
- Support continuous improvement of regulatory working processes
- Prepare for and participate in inspections as a subject matter expert
- Optimize the use of company software for regulatory management
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- internal data management systems
- documentation tools
Benefits
Modern Office
- Modern working environment
Flexible Working
- Hybrid working models
- Flexible working time models
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH 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.
About the Company
Sanofi-Aventis Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
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