Global Regulatory Affairs Lead

vor 2 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Global Regulatory Affairs Lead (Neurotoxins)

At Merz Therapeutics, we are seeking a highly skilled Global Regulatory Affairs Lead to join our team in Frankfurt am Main, Germany. As a key member of our Global Regulatory Affairs team, you will be responsible for shaping regulatory strategies and submission plans for new registrations and life cycle management of our Neurotoxin products.

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
  • Manage regulatory inquiries from authorities and implement necessary life cycle management activities
  • Coordinate regulatory projects and communicate with Merz representatives, partners, and consultants

Requirements:

  • Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field; a doctorate is an advantage
  • 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, with proficiency in English

What We Offer:

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

Join our international and motivated Merz Therapeutics family and help us achieve our goal: "Better Outcomes for More Patients".

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