Merz Therapeutics
Team Lead Regulatory Affairs Regions(m/w/x)
Full-timeWith HomeofficeSenior
Frankfurt am Main
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MEMerz Therapeutics
Regional Regulatory Affairs Manager(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Developing regulatory documentation and coordinating new submissions for EMEA pharmaceutical registrations. 3-5 years EMEA regulatory affairs experience with centralized procedure required. Hybrid work, individual career development.
Requirements
- Scientific studies in Pharmacy, Biology, Chemistry or related field; doctorate advantageous
- 3-5 years professional experience in EMEA regulatory affairs, specifically centralized procedure in pharma
- Strong problem-solving and analytical thinking skills
- Intercultural team player with persistence
- Strong communication skills, including profound English
Tasks
- Provide regional regulatory support
- Develop regulatory documentation for EMEA
- Maintain regulatory documentation for EMEA
- Coordinate new registration submissions
- Submit applications for approvals
- Coordinate GMP verification submissions
- Implement local regulatory changes
- Update product information texts
- Update packaging
- Manage regulatory life-cycle activities
- Manage renewals
- Manage variations
- Manage post-approval commitments
- Respond to deficiency letters
- Communicate regional regulatory needs
- Coordinate with local partners
- Manage third-party service providers
- Contribute to regulatory strategies
- Stay updated on regional requirements
- Stay updated on best practices
- Prepare for meetings with authorities
- Participate in meetings with authorities
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Native
Benefits
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
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
Regional Regulatory Affairs Manager(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Developing regulatory documentation and coordinating new submissions for EMEA pharmaceutical registrations. 3-5 years EMEA regulatory affairs experience with centralized procedure required. Hybrid work, individual career development.
Requirements
- Scientific studies in Pharmacy, Biology, Chemistry or related field; doctorate advantageous
- 3-5 years professional experience in EMEA regulatory affairs, specifically centralized procedure in pharma
- Strong problem-solving and analytical thinking skills
- Intercultural team player with persistence
- Strong communication skills, including profound English
Tasks
- Provide regional regulatory support
- Develop regulatory documentation for EMEA
- Maintain regulatory documentation for EMEA
- Coordinate new registration submissions
- Submit applications for approvals
- Coordinate GMP verification submissions
- Implement local regulatory changes
- Update product information texts
- Update packaging
- Manage regulatory life-cycle activities
- Manage renewals
- Manage variations
- Manage post-approval commitments
- Respond to deficiency letters
- Communicate regional regulatory needs
- Coordinate with local partners
- Manage third-party service providers
- Contribute to regulatory strategies
- Stay updated on regional requirements
- Stay updated on best practices
- Prepare for meetings with authorities
- Participate in meetings with authorities
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Native
Benefits
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
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
Team Lead Regulatory Affairs Regions(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - Merz Therapeutics
Regulatory Affairs Manager - Labeling & Regulatory Intelligence(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt 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 - STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorBad Vilbel