Strategic Regulatory Partner

vor 2 Monaten

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

Job Summary

We are seeking a highly skilled Global Regulatory Lead to join our team at Merz Therapeutics. As a key member of our Global Product Team, you will be responsible for shaping regulatory strategies and submission plans related to new registrations or life cycle management.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with national and international regulations
  • Collaborate with cross-functional teams to create high-quality documentation and registration procedures
  • Lead the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products
  • Ensure timely and accurate submission of applications to regulatory authorities
  • Manage and respond to inquiries from regulatory authorities
  • Implement regulatory life cycle management activities, including line extensions, annual reports, and post-approval commitments
  • Lead and coordinate regulatory projects, including communication with Merz representatives, partners, and consultants
  • Participate in scientific consultations with regulatory authorities worldwide

Requirements

  • Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field
  • At least 5 years of professional experience in regulatory affairs within the pharmaceutical industry
  • Strong knowledge of regulatory laws and regulations, including GMP and compliance aspects
  • Excellent communication and problem-solving skills
  • Team player with performance orientation and persistence

What We Offer

  • Individual career development in a purposeful job
  • Hybrid work model with a good work-life balance
  • Attractive location with good transport links and modern workplaces
  • Global family business with flat hierarchies and an open, respectful corporate culture
  • Attractive remuneration with extensive social benefits

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