Global Regulatory Affairs Lead

Vor 6 Tagen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Job Summary

We are seeking a highly skilled Global Regulatory Affairs 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 for our Neurotoxins products.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with national and international regulations
  • Prepare and submit high-quality documentation for regulatory approvals, including registration procedures and submissions
  • Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product life cycle
  • Lead the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products
  • Manage and respond to inquiries from regulatory authorities
  • Implement regulatory life cycle management activities, including line extensions, annual reports, post-approval commitments, change control, renewals, and import licenses
  • Coordinate regulatory projects and communicate with Merz representatives, partners, or consultants as a key regulatory member of the assigned Global Product Team
  • Participate in scientific consultations with regulatory authorities worldwide in close collaboration with country RAM and other regulatory functions
  • Support the creation of benefit dossiers or health technology assessments, price and reimbursement applications, and due diligence procedures as applicable
Requirements
  • Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field of studies; a doctorate is an advantage
  • At least 5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry
  • Strong knowledge of regulatory laws and regulations, including GMP and compliance aspects, as well as CMC documents
  • Excellent communication skills, including intercultural communication, and profound English language skills
  • Strong problem-solving skills and analytical thinking ability
  • Team player with performance orientation and persistence
What We Offer
  • Individual career development in a purposeful job: you improve the quality of life of our patients
  • Hybrid work model that allows a good work-life balance
  • Attractive location with good transport links, modern workplaces, and a company restaurant
  • Global family business with flat hierarchies and an open, respectful corporate culture
  • Attractive remuneration with extensive social benefits
  • Variety of employer-subsidized benefits, such as WellPass, Germany ticket, Corporate Benefits, and JobBike

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