Sanofi-Aventis Deutschland GmbH
Maintenance and Calibration Lead(m/w/x)
Full-timeOn-siteSenior
Frankfurt am Main
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SASanofi-Aventis Deutschland GmbH
Lead Regulatory Site Officer InsuLINK(m/w/x)
Frankfurt am Main
Full-timeOn-siteManagement
Nejo AI Summary
Leading regulatory site team for insulin products, authoring CTD dossiers for international market compliance. Significant biopharmaceutical Regulatory Affairs and leadership experience required. Direct reporting to Global Program Quality Head, managing a dedicated site team.
Requirements
- Significant industry experience in biopharmaceutical Regulatory Affairs
- Leadership experience with proven delivery and compliance
- In-depth knowledge of BLA process and Annex I
- Knowledge of CTD format and global regulatory requirements
- Strong technical regulatory writing skills
- Experience with health authority interactions
- Knowledge of GMP and quality systems
- Effective coaching and people development skills
- Degree in Science, Pharmacy, or equivalent qualification
- Proficiency in English
- Desirable knowledge of German and Chinese
Tasks
- Lead the InsuLINK regulatory site officer team
- Manage quality regulatory affairs within budget and schedule
- Report progress to the Global Program Quality Head
- Ensure insulin product compliance with international market regulations
- Author and manage CTD dossiers and technical documentation
- Define regulatory impacts for product and service changes
- Execute the regulatory compliance maintenance program
- Monitor and anticipate changes in the regulatory environment
- Implement regulatory procedures at the site level
- Maintain Site Master Files for both facilities
- Oversee regulatory aspects of product lifecycle management
- Lead health authority interactions and inspection preparations
- Coordinate responses to queries from global health agencies
- Oversee the quality regulatory affairs budget and costs
- Support quality systems implementation and GMP compliance
- Align regulatory strategies with Global Regulatory CMC
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- Chinese – Basic
Tools & Technologies
- BLA process
- Annex I
- CTD format
- GMP
- Quality systems
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
Lead Regulatory Site Officer InsuLINK(m/w/x)
Frankfurt am Main
Full-timeOn-siteManagement
Nejo AI Summary
Leading regulatory site team for insulin products, authoring CTD dossiers for international market compliance. Significant biopharmaceutical Regulatory Affairs and leadership experience required. Direct reporting to Global Program Quality Head, managing a dedicated site team.
Requirements
- Significant industry experience in biopharmaceutical Regulatory Affairs
- Leadership experience with proven delivery and compliance
- In-depth knowledge of BLA process and Annex I
- Knowledge of CTD format and global regulatory requirements
- Strong technical regulatory writing skills
- Experience with health authority interactions
- Knowledge of GMP and quality systems
- Effective coaching and people development skills
- Degree in Science, Pharmacy, or equivalent qualification
- Proficiency in English
- Desirable knowledge of German and Chinese
Tasks
- Lead the InsuLINK regulatory site officer team
- Manage quality regulatory affairs within budget and schedule
- Report progress to the Global Program Quality Head
- Ensure insulin product compliance with international market regulations
- Author and manage CTD dossiers and technical documentation
- Define regulatory impacts for product and service changes
- Execute the regulatory compliance maintenance program
- Monitor and anticipate changes in the regulatory environment
- Implement regulatory procedures at the site level
- Maintain Site Master Files for both facilities
- Oversee regulatory aspects of product lifecycle management
- Lead health authority interactions and inspection preparations
- Coordinate responses to queries from global health agencies
- Oversee the quality regulatory affairs budget and costs
- Support quality systems implementation and GMP compliance
- Align regulatory strategies with Global Regulatory CMC
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- Chinese – Basic
Tools & Technologies
- BLA process
- Annex I
- CTD format
- GMP
- Quality systems
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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Full-timeOn-siteSeniorBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
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Full-timeOn-siteExperiencedFrankfurt am Main