Merz Therapeutics
Regulatory Affairs Manager - Labeling & Regulatory Intelligence(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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MEMerz Therapeutics
Global Regulatory Lead - New Assets(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Nejo AI Summary
Shaping regulatory strategies for new pharmaceutical products, interfacing with Global Product Teams for movement disorder therapies. 5+ years regulatory affairs experience in pharma, with strong knowledge of regulatory laws, GMP, and CMC documents required. Hybrid work model.
Requirements
- Completed scientific studies in Pharmacy, Biology, Chemistry, or related field
- At least 5 years of professional experience in regulatory affairs within the pharmaceutical industry
- Very good knowledge of regulatory laws, GMP, compliance, and CMC documents
- Strong communication skills, including intercultural and business fluent English
- Strong problem-solving skills and analytical thinking ability
- Team player with performance orientation and persistence
Tasks
- Serve as the primary interface with the Global Product Team
- Shape regulatory strategies and submission plans for new registrations
- Create high-quality documentation for registration procedures
- Ensure compliance with internal and regulatory requirements
- Implement regulatory activities for new registration applications
- Lead the creation and maintenance of the Company Core Data Sheet
- Manage inquiries from regulatory authorities
- Implement regulatory life cycle management activities
- Lead and coordinate regulatory projects with Merz representatives
- Prepare for scientific consultations with regulatory authorities
- Support the creation of benefit dossiers and health technology assessments
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Other Benefits
- Attractive location
- Extensive social benefits
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
Competitive Pay
- Attractive remuneration
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
Global Regulatory Lead - New Assets(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Nejo AI Summary
Shaping regulatory strategies for new pharmaceutical products, interfacing with Global Product Teams for movement disorder therapies. 5+ years regulatory affairs experience in pharma, with strong knowledge of regulatory laws, GMP, and CMC documents required. Hybrid work model.
Requirements
- Completed scientific studies in Pharmacy, Biology, Chemistry, or related field
- At least 5 years of professional experience in regulatory affairs within the pharmaceutical industry
- Very good knowledge of regulatory laws, GMP, compliance, and CMC documents
- Strong communication skills, including intercultural and business fluent English
- Strong problem-solving skills and analytical thinking ability
- Team player with performance orientation and persistence
Tasks
- Serve as the primary interface with the Global Product Team
- Shape regulatory strategies and submission plans for new registrations
- Create high-quality documentation for registration procedures
- Ensure compliance with internal and regulatory requirements
- Implement regulatory activities for new registration applications
- Lead the creation and maintenance of the Company Core Data Sheet
- Manage inquiries from regulatory authorities
- Implement regulatory life cycle management activities
- Lead and coordinate regulatory projects with Merz representatives
- Prepare for scientific consultations with regulatory authorities
- Support the creation of benefit dossiers and health technology assessments
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Other Benefits
- Attractive location
- Extensive social benefits
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
Competitive Pay
- Attractive remuneration
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
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Full-timeWith HomeofficeExperiencedFrankfurt am Main - STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-timeWith HomeofficeSeniorBad Vilbel - Merz Therapeutics
Global Lead Medical Affairs Operations & Excellence(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - Merz Therapeutics
(Senior) Pharmacovigilance Officer Global Product Safety(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorBad Vilbel