Sanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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MEMerz Therapeutics
Regulatory CMC Writing Manager(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeManagement
Nejo AI Summary
Preparing and reviewing CMC documentation for pharmaceutical products across global manufacturing sites. Technical writing experience for Module 3 documentation required. Global family business culture.
Requirements
- Completed scientific studies in Pharmacy
- Doctorate is an advantage
- 3-5 years in regulatory affairs
- Experience with technical writing of module 3
- Strong communication skills
- Problem-solving skills
- Analytical thinking ability
- Team player with performance orientation
- Persistence
- Solution-oriented focus on compliance
- Focus on quality
- Business fluent in English
- German is an advantage
Tasks
- Prepare CMC documentation per internal requirements.
- Review draft documentation with CMC RA and site.
- Conduct initial impact assessments and document changes.
- Provide documentation according to LoQ scope and timeline.
- Coordinate information and documentation with manufacturing site.
- Support GMP inspections as required.
- Stay updated on global CMC regulations and best practices.
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Mentorship & Coaching
- Individual career development
Flexible Working
- Hybrid work model
Parking & Commuter Benefits
- Attractive location with transport links
Informal Culture
- Global family business culture
Competitive Pay
- Attractive remuneration with benefits
Corporate Discounts
- Employer-subsidized benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merz Therapeutics 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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MEMerz Therapeutics
Regulatory CMC Writing Manager(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeManagement
Nejo AI Summary
Preparing and reviewing CMC documentation for pharmaceutical products across global manufacturing sites. Technical writing experience for Module 3 documentation required. Global family business culture.
Requirements
- Completed scientific studies in Pharmacy
- Doctorate is an advantage
- 3-5 years in regulatory affairs
- Experience with technical writing of module 3
- Strong communication skills
- Problem-solving skills
- Analytical thinking ability
- Team player with performance orientation
- Persistence
- Solution-oriented focus on compliance
- Focus on quality
- Business fluent in English
- German is an advantage
Tasks
- Prepare CMC documentation per internal requirements.
- Review draft documentation with CMC RA and site.
- Conduct initial impact assessments and document changes.
- Provide documentation according to LoQ scope and timeline.
- Coordinate information and documentation with manufacturing site.
- Support GMP inspections as required.
- Stay updated on global CMC regulations and best practices.
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Mentorship & Coaching
- Individual career development
Flexible Working
- Hybrid work model
Parking & Commuter Benefits
- Attractive location with transport links
Informal Culture
- Global family business culture
Competitive Pay
- Attractive remuneration with benefits
Corporate Discounts
- Employer-subsidized benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merz Therapeutics 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
Merz Therapeutics
Industry
Pharmaceuticals
Description
Merz Therapeutics is a leading pharmaceutical company dedicated to improving the quality of life for people with movement disorders, neurological diseases, and other health conditions. With a 110-year history, the company is a global innovation leader with products in over 90 countries.
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