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Team Lead Regulatory Affairs Regions(m/w/x)
Leading international regulatory team for neurological and liver disease treatments. 5+ years line management experience required. Deutschland-Ticket, WellPass.
Requirements
- University degree in natural sciences or equivalent
- 10+ years in regulatory affairs or pharmaceutical industry
- 5+ years line management experience
- Ability to lead international team
- Comprehensive knowledge of international regulatory environment
- Regional regulatory experience for 2 regions (ideal)
- Project management experience
- Budget control experience
- Analytical and strategic thinking
- Compliancy and quality mindset
- Solution oriented
- Team player
- Strong negotiation skills
- Excellent English communication skills
- German language skills (plus)
Tasks
- Lead a regional team of 10 professionals
- Ensure timely and compliant execution of regional regulatory activities
- Drive process optimization across licenses, budget, and organization
- Collaborate with affiliates, partners, and CROs
- Provide regulatory expertise
- Support team development
- Ensure local input for global submissions
- Respond timely to authority requests with global teams
- Maintain licenses
- Update milestones for global regulatory reporting
- Align regional input with global strategy
- Coordinate key authority interactions
- Assess regional risks and opportunities for product acquisitions
- Support departmental goals
- Foster collaboration within the department
- Contribute to process improvement
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Additional Allowances
- Extensive social benefits
Career Advancement
- Individual career development
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Deutschland-Ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
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- Merz TherapeuticsFull-timeWith HomeofficeExperiencedFrankfurt am Main
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Team Lead Regulatory Affairs Regions(m/w/x)
Leading international regulatory team for neurological and liver disease treatments. 5+ years line management experience required. Deutschland-Ticket, WellPass.
Requirements
- University degree in natural sciences or equivalent
- 10+ years in regulatory affairs or pharmaceutical industry
- 5+ years line management experience
- Ability to lead international team
- Comprehensive knowledge of international regulatory environment
- Regional regulatory experience for 2 regions (ideal)
- Project management experience
- Budget control experience
- Analytical and strategic thinking
- Compliancy and quality mindset
- Solution oriented
- Team player
- Strong negotiation skills
- Excellent English communication skills
- German language skills (plus)
Tasks
- Lead a regional team of 10 professionals
- Ensure timely and compliant execution of regional regulatory activities
- Drive process optimization across licenses, budget, and organization
- Collaborate with affiliates, partners, and CROs
- Provide regulatory expertise
- Support team development
- Ensure local input for global submissions
- Respond timely to authority requests with global teams
- Maintain licenses
- Update milestones for global regulatory reporting
- Align regional input with global strategy
- Coordinate key authority interactions
- Assess regional risks and opportunities for product acquisitions
- Support departmental goals
- Foster collaboration within the department
- Contribute to process improvement
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Additional Allowances
- Extensive social benefits
Career Advancement
- Individual career development
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Deutschland-Ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
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
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Regulatory Affairs Manager - Labeling & Regulatory Intelligence(m/w/x)
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Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
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Global Lead Medical Affairs Operations & Excellence(m/w/x)
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