Merz Therapeutics

Regulatory Affairs Manager – Labeling and Regulatory Intelligence

Merz Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Frankfurt am Main • Germany

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About the role

  • Support regional regulatory strategies, approvals and life-cycle management of medicinal products, ensuring compliance with regulatory and legal requirements
  • Review Company Core Data Sheets (CCDS)
  • Implement CCDS into national product information texts (EEA/CH/UK), coordinate translations, and ensure compliance and timely delivery
  • Initiate, review and approve artwork changes (EEA/CH/UK) in close cooperation with local Regulatory Affairs teams
  • Support submissions and responses to regulatory authority queries
  • Optimize labeling and artwork processes; train colleagues and act as a key user for Merz’s artwork management system
  • Lead, monitor and further develop the Regulatory Intelligence process within global Regulatory Affairs

Requirements

  • University degree in a scientific discipline or Pharmacy; pharmacist license/qualification advantageous
  • Minimum 2 years’ professional experience in the pharmaceutical industry and Regulatory Affairs; experience in labeling is a plus
  • Strong knowledge of international regulatory frameworks and standards
  • Strong project management skills and analytical thinking
  • Team player with excellent communication and problem-solving skills
  • Fluent German and English (business fluent)
Benefits
  • Individual career development in a purpose-driven role — contribute to improving patients’ quality of life
  • Hybrid work model enabling a good work–life balance
  • Attractive location with good transport links, modern workspaces and a company canteen
  • Global family-owned company with flat hierarchies and an open, respectful corporate culture
  • Competitive compensation with comprehensive social benefits
  • Variety of employer-sponsored benefits such as WellPass, Germany ticket (Deutschland-Ticket), Corporate Benefits and JobBike
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategieslife-cycle managementCompany Core Data Sheets (CCDS)labelingartwork managementRegulatory Intelligence processproject managementanalytical thinking
Soft Skills
team playercommunicationproblem-solving
Certifications
university degree in scientific disciplinepharmacist license