Global Regulatory Affairs Lead

vor 4 Wochen

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

Merz Therapeutics is 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 management for our Neurotoxin products.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with national and international regulations
  • Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product life cycle
  • Prepare and submit high-quality regulatory documents, including registration procedures and applications
  • Lead the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products
  • Manage and respond to inquiries from regulatory authorities
  • Implement necessary regulatory life cycle management activities, including line extensions, annual reports, and post-approval commitments
  • Coordinate regulatory projects and communicate with Merz representatives, partners, or consultants as a key regulatory member of the Global Product Team
  • Participate in scientific consultations with regulatory authorities worldwide in close collaboration with country RAM and other regulatory functions

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
  • Excellent knowledge of regulatory laws and regulations, including GMP and compliance aspects, as well as CMC documents
  • Strong communication and problem-solving skills, with analytical thinking and intercultural communication
  • Team player with performance orientation and persistence

What We Offer:

  • Individual career development in a purposeful job, improving the quality of life for our patients
  • Hybrid work model for 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, including WellPass, Germany ticket, Corporate Benefits, and JobBike

Learn more about our benefits and company culture at our website.

  • Global Regulatory Affairs Lead

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Key Responsibilities:As a Global Regulatory Affairs Lead at Merz Therapeutics, you will be responsible for shaping regulatory strategies and submission plans related to new registrations or life cycle management for Neurotoxins. You will represent regulatory requirements worldwide and ensure compliance with internal requirements.Key Activities:Creating...

  • Global Regulatory Affairs Director

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Affairs LeadAt Merz Therapeutics, we are seeking a highly skilled Global Regulatory Affairs Lead to join our team in Frankfurt, 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 management for our...

  • Global Regulatory Affairs Specialist

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Global Regulatory Lead (m/w/d) New AssetsAs 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...

  • Regulatory Affairs Lead

    Vor 4 Tagen

    Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Lead to join our team at Grifols. As a key member of our regulatory affairs department, you will play a crucial role in ensuring that our products meet the highest regulatory standards.Job DescriptionThe Regulatory Affairs Lead will be responsible for coordinating European marketing...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland SCHOTT AG Vollzeit

    About SCHOTT AGWe are a leading international technology group in the areas of specialty glass and glass-ceramics. Our innovative solutions are used in various industries, including pharmaceuticals, optics, and life sciences. At SCHOTT AG, we are committed to sustainability and strive to make a positive impact on society and the environment.Your RoleWe are...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Therapeutics. As a Regulatory Affairs Manager, you will play a crucial role in ensuring the compliance of our medicinal products with global regulatory requirements.Key ResponsibilitiesCreate, review, and update high-quality CMC documentation to obtain and maintain...

  • Global Regulatory Affairs Specialist

    Vor 5 Tagen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Role OverviewAs a Global Regulatory Lead, you will serve as the primary interface and key strategic partner to Global Product Teams for New Assets and its maintenance. This role involves shaping regulatory strategies and submission plans, creating high-quality documentation, and ensuring compliance with internal and national regulatory requirements.Key...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

    Möchten Sie in einem internationalen Team mitarbeiten, um die Zukunft der Gesundheitsversorgung zu verbessern?Grifols ist ein globales Gesundheitsunternehmen, das seit seiner Gründung 1909 in Barcelona daran arbeitet, die Gesundheit und das Wohlbefinden von Menschen auf der ganzen Welt zu verbessern.Wir suchen einen Regulatory Affairs Manager, der den...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryMerz Therapeutics is seeking a highly skilled Regulatory Affairs Specialist to provide regional regulatory support for the strategic development, approval, and life cycle management of drugs. The ideal candidate will ensure compliance with regulatory and legal requirements in the assigned region.Key ResponsibilitiesDevelop and maintain...

  • Regional Regulatory Affairs Specialist

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe are seeking a highly skilled Regional Regulatory Affairs Manager to join our team at Merz Therapeutics. As a key member of our regulatory affairs department, you will be responsible for providing regional regulatory support for the strategic development, approval, and life cycle management of drugs.Key ResponsibilitiesDevelop and maintain...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Therapeutics. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with global regulatory requirements and supporting the approval and maintenance of medicinal products.Key ResponsibilitiesCreate, review, and update high-quality CMC...

  • Administrative Assistant

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Administrative Assistant - Global Regulatory AffairsWir suchen einen erfahrenen Büromanagement-Professional, der unsere internationale Zusammenarbeit unterstützt.Organisation von Meetings und VeranstaltungenErstellung von Präsentationen und Übersichten für Ressourcen- und BudgetplanungReisebuchung, Abrechnung und BüromaterialbestellungPflege des...

  • Regulatory Operations Lead

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    {"title": "Overview", "content": "Join Our TeamAt Merz Therapeutics, we are dedicated to improving treatment outcomes for patients around the world. We are seeking a highly skilled and motivated individual to join our team as Head of Regulatory Operations.", "subsections": [ {"title": "Responsibilities", "content": "Lead and develop the Global Regulatory...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Regulatory Affairs Manager (CMC)As a key member of our team, you will play a crucial role in ensuring the compliance and quality of our medicinal products. Your expertise in global regulatory requirements will be essential in supporting the approval and maintenance of our products.Key Responsibilities:Create, review, and update high-quality CMC documentation...

  • Regional Regulatory Affairs Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job SummaryMerz Therapeutics is seeking a highly skilled Regional Regulatory Affairs Manager to provide strategic support for the development, approval, and life cycle management of drugs in the assigned region. The successful candidate will ensure compliance with regulatory and legal requirements, coordinate applications for new registrations and approvals,...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

    Job Description:We are seeking a highly skilled Regulatory Affairs Manager to support the Technical Director in the development and implementation of the strategic regulatory plan. The role will have primary responsibility for European wide registrations and license maintenance to ensure timely approvals in alignment with Grifols European business...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

    Job Title: Regulatory Affairs ManagerGrifols is seeking a highly skilled Regulatory Affairs Manager to support the Technical Director in the development and implementation of the strategic regulatory plan. The successful candidate will have primary responsibility for European wide registrations and license maintenance to ensure timely approvals in alignment...

  • Regulatory Affairs Manager/in

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Lifecare Vollzeit

    Regulatory Affairs Manager/inWir suchen einen erfahrenen Regulatory Affairs Manager/in, der unsere Kosmetika, Nahrungsergänzungsmittel, Arzneimittel und Medizinprodukte erfolgreich auf dem Markt platzieren kann.VerantwortlichkeitenRegulatorische und wissenschaftliche Bewertung von ProduktenEntwicklung von Formulierungen und VerpackungenSteuerung von...

  • Regulatory Affairs Berater

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland LORENZ Life Sciences Group Vollzeit

    Bei LORENZ Life Sciences Group suchen wir einen motivierten Regulatory Affairs Berater, der gemeinsam mit unserem Team die Effizienz des Arzneimittelzulassungsprozesses steigern möchte.Deine AufgabenDu analysierst und dokumentierst die bestehenden Prozesse unserer Kunden und hilfst ihnen, ihre Konfigurationsanforderungen zu definierenDu unterstützt die...

  • Regulatory Affairs Expert für Arzneimittelzulassung

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland LORENZ Life Sciences Group Vollzeit

    Unser Unternehmen LORENZ Life Sciences Group ist ein führender Anbieter von Softwarelösungen für den digitalen Datenaustausch zwischen der pharmazeutischen Industrie und den Zulassungsbehörden. Wir suchen einen motivierten Regulatory Affairs Experten, der gemeinsam mit unserem Team die Effizienz des Arzneimittelzulassungsprozesses steigern möchte.Deine...