Jobs
>
Zürich

    Regulatory Affairs Manager 80 - Zürich, Schweiz - headcount AG

    headcount AG
    headcount AG Zürich, Schweiz

    vor 18 Stunden

    Default job background
    Ganztags
    Beschreibung
    Regulatory Affairs CMC Manager

    As we are seeing a paradigm shift within the biotech industry, the growth antimicrobial resistance is a leading concern for all those involved. Our client is at the forefront in developing innovative vaccines agaisnt AMR pathogens and in order to ramp up their manufacturing activites, they are looking for a Regulatory Affairs CMC manager with a strong scientific background to support the CMC team. Reporting to the Director of CMC, your responsilbilities will include.

    Responsibilities:
    • Managing regulatory operations for our vaccine candidates as they progress toward the market
    • Selecting, qualifying, and managing CMC partners for quality and regulatory aspects
    • Supporting the internal Quality Management System (QMS), including internal self-inspections
    • Managing global CMC submission activities
    • Co-authoring and managing regulatory CMC documentation in compliance with applicable regulations and internal procedures
    • Initiating, maintaining, and leading Regulatory Authority correspondence and negotiations, setting objectives, and developing risk mitigation plans
    Profile:
    • A university degree in life or pharmaceutical sciences
    • Minimum of 3 years' CMC experience in the biotech or pharmaceutical industry, with at least 2 years in Regulatory Affairs (preferably with different Regulatory Agencies)
    • Solid technical regulatory expertise. Experience in QbD, process and analytical validation, CMC-bridging strategies and with different regulatory authorities is a plus
    • Excellent verbal and written communication skills in English
  • Takeda Pharmaceutical

    Regulatory Affairs Manager

    vor 1 Tag

    Takeda Pharmaceutical Zurich, Schweiz

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and ...

  • Pfizer

    Regulatory Affairs Manager

    vor 1 Tag

    Pfizer Zurich, Schweiz

    Regulatory Affairs Manager (M/F/d) · time type: 60%/80%/100% · This is what you can look forward to: · - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background · - Handling entire regulatory lifecycle from initial MAAs to line ex ...

  • bruederlinpartner

    Regulatory Affairs Manager

    vor 2 Tagen

    bruederlinpartner Zürich, Schweiz Ganztags

    Sie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschritt · bruederlinpartner bringt als spezialisierter Personaldienstleister jeden ...

  • Amino AG

    Regulatory Affairs Manager

    vor 3 Tagen

    Amino AG Gebenstorf, Schweiz

    Wir sind eine kleine Firmengruppe, welche eigene Arzneimittel herstellt. Um die · hohen behördlichen Anforderungen zu erfüllen, suchen wir zur Verstärkung unseres · Teams per sofort oder nach Vereinbarung eine / n hochmotivierte / n · **Regulatory Affairs Specialist/Manager %** · ...

  • CH Media Holding AG

    Manager Public Affairs

    vor 1 Tag

    CH Media Holding AG Aarau, Schweiz

    CH Media ist eines der führenden Schweizer Medienunternehmen und beschäftigt in der Deutschschweiz rund... · weiterlesen · CH Media ist eines der führenden Schweizer Medienunternehmen und beschäftigt in der Deutschschweiz rund 1800 Mitarbeitende. Mit ihren Tages · - und Wochenzei ...

  • Mondelēz International

    Manager Communications and Government Affairs Meu

    vor 1 Tag

    Mondelēz International Zurich, Schweiz

    **Job Description**: · **Are You Ready to Make It Happen at Mondelēz International?** · **Join our Mission to Lead the Future of Snacking. Make It Matter.** · In this role, you will define, implement and coordinate all internal communications activities across Europe and will be ...

  • Astellas

    Associate Regulatory Affairs Manager

    vor 1 Tag

    Astellas Wallisellen, Schweiz

    About Astellas: · At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. · Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing goo ...

  • Universal-Job

    Manager Medical Affairs 60%

    vor 1 Tag

    Universal-Job Rotkreuz, Schweiz

    In dieser Position sind Sie zuständig für die Beantwortung medizinischer Anfragen von Ärzten, Apothekern und Patienten zu den Produkten unter Zuhilfenahme von entsprechenden internen Datenbanken, Literatur-Recherchen und anderen wissenschaftlichen Informationsquellen, sowie mediz ...

  • Louis Widmer SA

    Regulatory Affairs Manager

    vor 6 Tagen

    Louis Widmer SA Schlieren, Schweiz

    IHRE HAUPTAUFGABEN: · Selbstständiges Vorbereiten, Planen und Einreichen von Zulassungsunterlagen für dermatologische Arzneimittel (Rx und OTC) in der EU (DE, AT, BE, NL) und CH (Stellvertretung) EU: Nationale wie MRP-Verfahren · Selbstständiges Erstellen und Bewertung von Zulass ...

  • Universal-Job

    Regulatory Affairs Manager

    vor 1 Tag

    Universal-Job Baar, Schweiz

    In this role you are responsible for leading regional regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialisation. Your acc ...

  • Swiss Re

    Public Affairs Manager

    vor 18 Stunden

    Swiss Re Zürich, Schweiz

    About the role · As a Public Affairs Manager, you will be responsible for positioning Swiss Re as a thought leader and leading risk knowledge company. You'll be building Swiss Re's reach and influence with decision makers and engaging us in the global discussions and debates un ...

  • Novo Nordisk

    Regulatory Affairs Manager

    vor 5 Tagen

    Novo Nordisk Zurich, Schweiz

    Are you ready to shape regulatory strategies for Switzerland? Are you an ambitious and experienced regulatory affairs manager being ready to take the next step and thereby making a meaningful impact? · If yes, we have a new exiting opportunity for you as our new Regulatory Affair ...

  • Swiss Re

    Public Affairs Manager

    vor 5 Tagen

    Swiss Re Zurich, Schweiz

    About the role · As a Public Affairs Manager, you will be responsible for positioning Swiss Re as a thought leader and leading risk knowledge company. You'll be building Swiss Re's reach and influence with decision makers and engaging us in the global discussions and debates un ...

  • Swiss Re AG

    Public Affairs Manager

    vor 3 Tagen

    Swiss Re AG Zurich, Schweiz Nebenberuflich

    Location: · Zurich, Zurich, CH · Public Affairs Manager (m/f/x/d, 80-100% Hybrid) · About the role · As a Public Affairs Manager, you will be responsible for positioning Swiss Re as a thought leader and leading risk knowledge company. You'll be building Swiss Re's reach and in ...

  • Swiss Re AG

    Public Affairs Manager

    vor 1 Woche

    Swiss Re AG Zurich, Schweiz Nebenberuflich

    Location: · Zurich, Zurich, CH · Public Affairs Manager (m/f/x/d, 80-100% Hybrid) · About the role · As a Public Affairs Manager, you will be responsible for positioning Swiss Re as a thought leader and leading risk knowledge company. You'll be building Swiss Re's reach and in ...

  • Swiss Re

    Public Affairs Manager

    vor 1 Woche

    Swiss Re Zurich, Schweiz

    About the role · As a Public Affairs Manager, you will be responsible for positioning Swiss Re as a thought leader and leading risk knowledge company. You'll be building Swiss Re's reach and influence with decision makers and engaging us in the global discussions and debates un ...

  • Novo Nordisk Health Care AG

    Regulatory Affairs Manager

    vor 22 Stunden

    Novo Nordisk Health Care AG Zurich, Schweiz Ganztags

    Position · Regulatory Affairs Manager (100%) · Stellenbeschreibung · Stellenbeschreibung · Ort · Zurich, Switzerland · Stellenkategorie · Reg Affairs & Safety Pharmacovigilance · Bewirb dich jetzt · Are you ready to shape regulatory strategies for Switzerland? Are you an ambitiou ...

  • Novo Nordisk Health Care AG

    Regulatory Affairs Manager

    vor 1 Woche

    Novo Nordisk Health Care AG Zurich, Schweiz Ganztags

    Position · Regulatory Affairs Manager (100%) · Stellenbeschreibung · Stellenbeschreibung · Ort · Zurich, Switzerland · Stellenkategorie · Reg Affairs & Safety Pharmacovigilance · Bewirb dich jetzt · Are you ready to shape regulatory strategies for Switzerland? Are you an ambitiou ...

  • CH Media

    Manager Public Affairs

    vor 2 Tagen

    CH Media Aarau, Schweiz

    % · In diesem vielfältigen Job · verantwortest und steuerst du die medienpolitischen und regulatorischen Dossiers · analysierst du politische Entwicklungen, Gesetzgebungsverfahren und regulatorische Initiativen auf nationaler und lokaler Ebene · entwickelst du Public-Affairs-Stra ...

  • SKYGUIDE, Société Anonyme Suisse pour les Services de la Navigation Aérienne civils et militaires

    Public Affairs Manager

    vor 2 Tagen

    SKYGUIDE, Société Anonyme Suisse pour les Services de la Navigation Aérienne civils et militaires Dübendorf, Schweiz Ganztags

    Skyguide provides air navigation services in Switzerland and parts of neighbouring countries. With around 1500 employees from more than 30 nations, · we are pursuing an ambitious innovation strategy that is based on a strong safety and learning culture. · We are guided by four v ...