Global Regulatory Lead

Vor 6 Tagen

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; 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, including intercultural communication
  • 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
  • Variety of employer-subsidized benefits

  • Global Regulatory Affairs Lead

    vor 10 Stunden

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    {"h1": "Global Regulatory Affairs Lead", "p": "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 related to new registrations or life cycle...

  • Global Regulatory Affairs Lead

    vor 10 Stunden

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    {"h1": "Global Regulatory Affairs Lead", "p": "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 related to new registrations or life cycle...

  • Global Regulatory Affairs Lead

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement...

  • Global Regulatory Affairs Lead

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement...

  • Global Regulatory Affairs Lead

    Vor 7 Tagen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement...

  • Global Regulatory Affairs Lead

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Lead (m/w/d) New AssetsFull TimeWith Professional ExperienceYOUR ROLEAs the Global Regulatory Lead, you will serve as the primary liaison and essential strategic partner to the Global Product Team (GPT) throughout the product lifecycle concerning New Assets and their ongoing management. Your responsibilities will encompass:Formulating...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Lead (m/w/d) New AssetsFull TimeWith Professional ExperienceYOUR ROLEAs the Global Regulatory Lead (GRL), you will serve as the principal liaison and strategic collaborator with the Global Product Team (GPT) throughout the product lifecycle concerning New Assets and their ongoing management. Your responsibilities will encompass:Developing...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Lead (m/w/d) New AssetsFull TimeWith Professional ExperienceYOUR CONTRIBUTIONAs the Global Regulatory Lead, you will serve as the principal liaison and strategic collaborator with the Global Product Team (GPT) throughout the product lifecycle for New Assets. Your responsibilities will encompass:Developing regulatory strategies and...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Lead (m/w/d) New AssetsFull TimeWith Professional ExperienceYOUR ROLEAs the Global Regulatory Lead, you will serve as the primary liaison and strategic partner to the Global Product Team (GPT) throughout the product lifecycle for New Assets. Your responsibilities will encompass:Developing regulatory strategies and submission plans for new...

  • Global Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Lead (m/w/d) New AssetsFull TimeWith Professional ExperienceYOUR CONTRIBUTIONAs the Global Regulatory Lead (GRL), you will serve as the principal liaison and strategic partner to the Global Product Team (GPT) throughout the product lifecycle for New Assets. Your responsibilities will encompass:Developing regulatory strategies and submission...

  • Strategic Regulatory Partner

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Strategic Regulatory Partner

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Global Regulatory Expert

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Therapeutics. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our medicinal products with global regulatory requirements.Key ResponsibilitiesCMC Documentation: Develop, review, and maintain...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe 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 ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Manager of Regulatory Affairs

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Manager of Regulatory Affairs (m/f/d) CMCPosition Summary:Accountable for leveraging expertise in global regulatory quality standards to facilitate the approval and ongoing compliance of pharmaceutical products.Responsibilities encompass the creation, assessment, and revision of CMC documentation, executing change control protocols, addressing inquiries from...

  • CMC Regulatory Compliance Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Manager of Regulatory Affairs (m/f/d) CMCPosition Summary:Accountable for leveraging expertise in global regulatory quality standards to facilitate the approval and ongoing management of pharmaceutical products.Responsibilities encompass the development, assessment, and modification of CMC documentation, execution of change control protocols, addressing...

  • Global Quality Assurance Process Leader

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Corden Pharma International GmbH Vollzeit

    CordenPharma International GmbH is a prominent player in the Contract Development and Manufacturing Organization (CDMO) sector, specializing in the development and production of active pharmaceutical ingredients, medications, and associated packaging services for our clients as a comprehensive service provider. Our commitment to excellence drives us to...

  • Quality and Regulatory Affairs Lead

    Vor 7 Tagen

    Frankfurt am Main, Hessen, Deutschland CM Medical Recruitment Vollzeit

    Job SummaryCM Medical Recruitment is seeking a highly skilled Quality and Regulatory Affairs Lead to oversee the distribution of medical devices, pharmaceuticals, and combination devices across the EMEAI region. The successful candidate will be responsible for ensuring high-quality and compliant distribution, while also supporting re-labelling activities and...