Merz Therapeutics

Global Regulatory Lead – New Assets

Merz Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Frankfurt am Main • 🇩🇪 Germany

Visit company website
✨ AI Apply
Apply

Job Level

Senior

About the role

  • Develop regulatory strategies and submission plans related to new registrations and lifecycle management
  • Prepare high-quality documentation and execute necessary registration procedures while ensuring compliance
  • Ensure and carry out the required regulatory activities to prepare and submit applications for new registrations
  • Lead the development and maintenance of the Company Core Data Sheet (CCDS)
  • Respond to regulatory authority inquiries
  • Lead and coordinate regulatory projects and communicate with the relevant Merz representatives, partners, or consultants

Requirements

  • University degree in Pharmacy, Biology, Chemistry, or a related discipline; a PhD is an advantage
  • At least 5 years of professional experience handling regulatory affairs in the pharmaceutical sector
  • Strong knowledge of regulatory laws and regulations, including GMP and compliance aspects, as well as CMC documentation
  • Excellent communication skills, including intercultural communication and very good English (at least business fluent)
  • Strong problem-solving skills and analytical thinking
  • Team player with a performance-driven mindset and perseverance
Benefits
  • Individual career development in a meaningful role: you improve the quality of life for our patients!
  • Hybrid working model enabling a good work–life balance
  • Attractive location with good transport links, modern workplaces, and an on-site company canteen
  • Global family-owned company with flat hierarchies and an open, respectful corporate culture
  • Competitive compensation with comprehensive social benefits
  • Variety of employer-supported benefits such as WellPass, Deutschland-Ticket, Corporate Benefits, and JobRad (JobBike)

Applicant Tracking System Keywords

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

Hard skills
regulatory strategiessubmission plansregistration procedurescomplianceCompany Core Data Sheet (CCDS)regulatory activitiesCMC documentationGMPregulatory lawsdocumentation preparation
Soft skills
communication skillsintercultural communicationproblem-solving skillsanalytical thinkingteam playerperformance-driven mindsetperseverance
Certifications
PhD