Global Regulatory Affairs Intercontinental

Vor 2 Tagen


Bern, Schweiz CSL Behring Vollzeit

**Responsibilities**:

- Plan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals needed to conduct current and future business activities; and produce, sell, and distribute its goods and services.
- Support development of consistent roles and work processes.
- Oversee development of plans, cost estimates, and schedules.
- Acquire the necessary permits and approvals.
- Monitor regulatory developments and advise management on the potential impact of regulations on the organization.
- Establish and maintain positive relationships with government agencies and other regulatory authorities.
- Represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization's interests are advanced.
- Prepare materials for legal counsel or external consultants.
- Regulatory system, data entry and maintenance in/of regulatory systems.

**Qualifications**:

- Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage.
- 3+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred.

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:



  • Bern, Schweiz Consultys Switzerland Vollzeit

    Job DescriptionThe Global Regulatory Lead (GRL) Consultant is a member of a GRA Global Product Strategy Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as:Regulatory leaders, who drive development and implementation of innovative, scientifically sound, prospective, global regulatory strategies for product/s,...


  • Bern, Schweiz CSL Behring Vollzeit

    Do you want to work in a global team and support worldwide registrations for Albumins? The Global Regulatory Affairs CMC Scientist is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The...


  • Bern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Regulatory & Clinical Affairs Specialist, BernClient:headcount AGLocation:BernJob Category:OtherJob Reference:17982f88f11aJob Views:5Posted:21.01.2025Expiry Date:07.03.2025Job Description:Regulatory & Clinical Affairs SpecialistExperts in developing devices for minimally invasive surgery and imaging, my client in...


  • Bern, Schweiz headcount AG Vollzeit

    Regulatory & Clinical Affairs SpecialistExperts in developing devices for minimally invasive surgery and imaging, my client in their growth phase has partnered with me to find the right fit! We are seeking a dedicated professional with grit to manage the registrations and compliance efforts for their award-winning products in the EU & US. This hybrid...


  • Bern, Schweiz InnoMedica Holding AG Vollzeit

    **INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...


  • Bern, Schweiz Parexel Vollzeit

    Are you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team! The role can be home or office based in various European...


  • Bern, Schweiz SciPro Vollzeit

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from SciProPrincipal Specialist Consultant at SciPro - Medical Devices & Digital Health across DACHThis position focuses on managing and updating regulatory documentation to ensure compliance with international standards. Key responsibilities...


  • Bern, Schweiz Guided Solutions Vollzeit

    Our customer is a leading Swiss SME and developer of cutting edge High-Tech Medical Device technology. A disruptor in their field with a strong Engineering core originating at Bern University, though now employing some of the brightest minds in Electronics, Mechatronics, physics and Software development. We have been tasked to identify and recruit a...


  • Bern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Regulatory and Clinical Affairs Specialist, BernClient:CASCINATION AGLocation:BernJob Category:OtherJob Reference:0e25671dc31eJob Views:7Posted:21.01.2025Expiry Date:07.03.2025Job Description:Your missionYou will be responsible for the development and upkeep of regulatory documentation to ensure compliance with...


  • Bern, Schweiz CSL Behring Vollzeit

    **Position Purpose**: The Dir., Sr. Global Regulatory Lead, Hematology TA, is a member of a GRA GPS Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as: - ** GRA** Representatives** **on Product/Project Strategy Teams (PSTs), key Delivery Teams (e.g., Clinical Development Teams [CDTs], Safety Management Teams...


  • Bern, Schweiz LHH Vollzeit

    Für unseren Mandanten, ein global agierendes mittelständisches Unternehmen mit über 20 Jahren Erfahrung in der Pharmabranche, suchen wir zum nächstmöglichen Zeitpunkt einen **Regulatory Affairs Manager (m/w/d)**. Unser Mandant zeichnet sich durch flache Hierarchien, ein familiäres Miteinander und eine täglich gelebte Wertschätzung...


  • Bern, Schweiz pharma-jobs24.ch Vollzeit

    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 Tag Fach- und Führungskräfte mit nationalen und internationalen Unternehmen...


  • Bern, Schweiz Cascination AG Vollzeit

    Your missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...


  • Bern, Schweiz CASCINATION AG Vollzeit

    Your missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include: Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...


  • Bern, Schweiz Vetoquinol AG Vollzeit

    **Arbeitspensum: 80-100%** **Ihre Aufgaben**: - Innerhalb eines kleinen Teams sind Sie mitverantwortlich für die GMP Compliance und Zulassungskonformität unserer tiermedizinischen Produkte sowie die GDP Compliance der Lieferkette. - Zudem wirken Sie mit bei allen regulatorischen Zulassungsaufgaben entsprechend den gesetzlichen Richtlinien und den...


  • Bern, Schweiz CSL Behring Vollzeit

    In this challenging and important role you will be expected to: **1) Lead CTA activities for global clinical trials during the entire study lifecycle** - Develop the CTA submission strategy for clinical trials - Act as an accountable interface regarding regulatory CTA topics within Regulatory and between Regulatory and other key functions, and providing...


  • Bern, Schweiz CASCINATION Vollzeit

    Your missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...


  • Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector. Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the...


  • Verwaltungsregion Bern-Mittelland, Schweiz CASCINATION AG Vollzeit

    Your missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...


  • Bern, Schweiz Air Liquide Vollzeit

    **Unternehmenspräsentation** AIR LIQUIDE** ist ein Weltmarktführer bei Gasen, Technologien und Services für Industrie und Gesundheit. Mit rund 66.400 Mitarbeitern in 75 Ländern versorgt Air Liquide mehr als 3,8 Millionen Kunden und Patienten. Sauerstoff, Stickstoff und Wasserstoff sind kleine Moleküle von grundlegender Bedeutung für das Leben, für die...