Merz Therapeutics
Global Regulatory Lead - New Assets(m/w/x)
Full-timeWith HomeofficeSenior
Frankfurt am Main
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MEMerz Therapeutics
Regulatory Affairs Manager - Labeling & Regulatory Intelligence(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Reviewing and implementing Company Core Data Sheets and artwork changes for national product information texts in Pharma for movement disorders. Pharmacist license and 2+ years of regulatory affairs experience in pharma required. Hybrid work model.
Requirements
- Completed scientific studies in natural sciences or pharmacy
- Pharmacist license
- 2+ years of professional experience in pharmaceutical industry
- Experience in regulatory affairs
- Experience with labeling
- Strong knowledge of international regulatory frameworks and standards
- Strong project management and analytical thinking ability
- Team player with excellent communication and problem-solving abilities
- Business fluent in German and English
Tasks
- Review Company Core Data Sheets (CCDS)
- Implement CCDS into national product information texts for EEA, CH, and UK
- Coordinate translations and ensure compliance and timely provision
- Initiate, review, and approve artwork changes for EEA, CH, and UK
- Collaborate closely with local regulatory affairs
- Support submissions and responses to authority queries
- Optimize labeling and artwork processes
- Train colleagues on the artwork management system
- Act as a key user for Merz’ artwork management system
- Lead and monitor the Regulatory Intelligence process in Global Regulatory Affairs
- Further develop the Regulatory Intelligence process
Work Experience
- 2 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Competitive Pay
- Attractive remuneration
Other Benefits
- Extensive social benefits
- Attractive location
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
Informal Culture
- Flat hierarchies
- Open corporate culture
Additional Allowances
- Employer-subsidized benefits
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Deutschland-ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
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 Affairs Manager - Labeling & Regulatory Intelligence(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Reviewing and implementing Company Core Data Sheets and artwork changes for national product information texts in Pharma for movement disorders. Pharmacist license and 2+ years of regulatory affairs experience in pharma required. Hybrid work model.
Requirements
- Completed scientific studies in natural sciences or pharmacy
- Pharmacist license
- 2+ years of professional experience in pharmaceutical industry
- Experience in regulatory affairs
- Experience with labeling
- Strong knowledge of international regulatory frameworks and standards
- Strong project management and analytical thinking ability
- Team player with excellent communication and problem-solving abilities
- Business fluent in German and English
Tasks
- Review Company Core Data Sheets (CCDS)
- Implement CCDS into national product information texts for EEA, CH, and UK
- Coordinate translations and ensure compliance and timely provision
- Initiate, review, and approve artwork changes for EEA, CH, and UK
- Collaborate closely with local regulatory affairs
- Support submissions and responses to authority queries
- Optimize labeling and artwork processes
- Train colleagues on the artwork management system
- Act as a key user for Merz’ artwork management system
- Lead and monitor the Regulatory Intelligence process in Global Regulatory Affairs
- Further develop the Regulatory Intelligence process
Work Experience
- 2 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Competitive Pay
- Attractive remuneration
Other Benefits
- Extensive social benefits
- Attractive location
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
Informal Culture
- Flat hierarchies
- Open corporate culture
Additional Allowances
- Employer-subsidized benefits
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Deutschland-ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
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
Das Unternehmen ist ein führendes Pharma-Unternehmen, das Menschen mit Bewegungsstörungen und anderen gesundheitlichen Beschwerden hilft.
Not a perfect match?
- Merz Therapeutics
Global Regulatory Lead - New Assets(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - Merz Therapeutics
Regulatory CMC Writing Manager(m/w/x)
Full-timeWith HomeofficeManagementFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-timeWith HomeofficeSeniorBad Vilbel - Lilly Deutschland GmbH
Associate Director - Patient Safety and Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeExperiencedBad Homburg vor der Höhe