Global Regulatory Affairs Specialist

vor 2 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Global Regulatory Lead (m/w/d) New Assets

As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping regulatory strategies and submission plans for new registrations and life cycle management. Your expertise will ensure compliance with national regulatory requirements and internal processes.

  • Develop and implement regulatory strategies and submission plans for new registrations and life cycle management
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and internal processes
  • Lead the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products
  • Manage inquiries from authorities and implement necessary regulatory life cycle management activities
  • Coordinate regulatory projects and communicate with Merz representatives, partners, or consultants

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

Benefits:

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

Learn more about our benefits here.

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