Merz Therapeutics

Regulatory Affairs Manager, Labeling & Regulatory Intelligence

Merz Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Frankfurt am Main • 🇩🇪 Germany

Visit company website
✨ AI Apply
Apply

Job Level

JuniorMid-Level

About the role

  • Support regional regulatory strategies, authorizations and lifecycle management of medicinal products, ensuring compliance with regulatory and legal requirements
  • Review Company Core Data Sheets (CCDS)
  • Implement CCDS into national product information (EEA/CH/UK), coordinate translations, ensure compliance and timely availability
  • 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; pharmacy license advantageous
  • 2+ years of professional experience in the pharmaceutical industry and in Regulatory Affairs; experience in labeling is an advantage
  • Strong knowledge of international regulatory frameworks and standards
  • Strong project management and analytical thinking skills
  • Team player with excellent communication and problem-solving abilities
  • Business-fluent German and English
Benefits
  • Individual career development in a meaningful role: you help improve patients’ quality of life
  • Hybrid working model for a good work–life balance
  • Attractive location with good transport links, modern workspaces and a company cafeteria
  • Global family-owned company with flat hierarchies and an open, respectful corporate culture
  • Competitive compensation with comprehensive social benefits
  • A variety of employer-funded additional benefits such as WellPass, 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
regulatory strategieslifecycle managementlabelingproject managementanalytical thinking
Soft skills
communicationproblem-solvingteam player
Certifications
pharmacy license