Regional Regulatory Affairs Specialist

Vor 5 Tagen


Bern, Bern, Schweiz CSL Vollzeit

Job Purpose:

We are seeking a highly experienced Regulatory Affairs Specialist to lead our Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of our Global Regulatory Affairs team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications for development products and change applications for registered products to obtain Health Authority approval in the fastest way.

Main Responsibilities:

  • You will ensure compliance with CSL's Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
  • As a Subject Matter Expert on regional regulatory procedures and Health Authority requirements, you will develop regional regulatory strategies, participate in GRA Strategy Team meetings, and contribute to complex project strategy documents.
  • You will coordinate submissions, responses to HA questions, and participate in Scientific Advice Meetings.
  • You will report to the Global Regulatory Affairs, Head Region Intercontinental.
  • The position is based in Switzerland.

Qualifications:

  • Degree in Biological or Medical Science or Pharmacy (preferably with a post-graduate qualification). Degree in Drug Regulatory Affairs is advantageous.
  • 10+ years of regulatory experience of scientific principles, and familiarity with GMP, GCP, and GLP.
  • Demonstrated leadership, adaptability, and excellent communication skills.

Our Benefits:

We encourage you to make your well-being a priority. It's essential and so are you.



  • Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking a highly experienced Regulatory Affairs Specialist to lead our Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of our Global Regulatory Strategy Team, you will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications for development products and change...


  • Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

    {"title": "Regulatory Affairs Specialist Immunology", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our Immunology team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local and regional regulations, communicating effectively with regulatory agencies, and...


  • Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Your MissionWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will be responsible for ensuring the development and upkeep of regulatory documentation to guarantee compliance with global standards.Key responsibilities include:Developing and executing...


  • Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Your MissionWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will be responsible for ensuring the development and upkeep of regulatory documentation to guarantee compliance with global standards.Develop and execute regulatory strategies aligned with...


  • Bern, Bern, Schweiz Gi Group SA Vollzeit

    Job Title: Regional Regulatory Lead Immunology, Respiratory, TransplantWe are seeking a highly skilled Regional Regulatory Lead Immunology, Respiratory, Transplant to join our team at Gi Group SA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local and regional regulations for our Immunology,...


  • Bern, Bern, Schweiz Gi Group SA Vollzeit

    Job Title: Regional Regulatory Lead Immunology, Respiratory, TransplantWe are seeking a highly skilled Regional Regulatory Lead Immunology, Respiratory, Transplant to join our team at Gi Group SA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local and regional regulations for our Immunology,...


  • Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Your MissionWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will play a critical role in ensuring the development and upkeep of regulatory documentation to ensure compliance with global standards.Develop and execute regulatory strategies aligned with...


  • Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

    Job Title: Regional Regulatory Lead Immunology, Respiratory, TransplantGi Life Sciences Basel is seeking a highly skilled Regional Regulatory Lead Immunology, Respiratory, Transplant to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local requirements and aligning all regulatory...


  • Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

    Key ResponsibilitiesAs a Regional Regulatory Lead for Immunology, Respiratory, and Transplant products, you will be responsible for aligning all regulatory activities with regional and global strategies, ensuring compliance with local requirements.You will communicate effectively to ensure that dossiers meet regional and local content and format...


  • Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

    Job SummaryWe are seeking a highly skilled Regional Regulatory Lead Immunology to join our team at Gi Life Sciences Basel. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and aligning regulatory activities with regional and global strategies.Key ResponsibilitiesLead regional regulatory...


  • Bern, Bern, Schweiz Gi Group SA Vollzeit

    Job Title: Regional Regulatory Lead Immunology, Respiratory, TransplantWe are seeking a highly skilled Regional Regulatory Lead Immunology, Respiratory, Transplant to join our team at Gi Group SA.Key Responsibilities:Act as a Regional Regulatory Lead for the assigned product portfolio (therapeutic area Immunology, Respiratory, Transplant) and countriesAlign...


  • Bern, Bern, Schweiz Gi Group SA Vollzeit

    Job Title: Regional Regulatory Lead Immunology, Respiratory, TransplantAbout the Role:We are seeking a highly skilled Regional Regulatory Lead to join our team in Bern. As a key member of our regulatory department, you will be responsible for ensuring compliance with local requirements and aligning all regulatory activities with regional and global...


  • Bern, Bern, Schweiz bruederlinpartner Vollzeit

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at bruederlinpartner. As a Regulatory Affairs Manager, you will be responsible for developing and implementing regulatory strategies, ensuring compliance with national and international regulations, and coordinating with internal departments, external advisors, and...


  • Bern, Bern, Schweiz bruederlinpartner Vollzeit

    Position: Regulatory Affairs ManagerWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Region Bern unterstützt.Aufgaben:Entwicklung und Umsetzung von regulatorischen StrategienEinreichung von Zulassungsanträgen bei nationalen und internationalen BehördenKontinuierliche Überwachung und Bewertung von Gesetzesänderungen und...


  • Bern, Bern, Schweiz bruederlinpartner Vollzeit

    Position als Regulatory Affairs ManagerWir suchen einen erfahrenen Regulatory Affairs Manager, der sich auf die Entwicklung und Umsetzung von regulatorischen Strategien spezialisiert hat. Der Kandidat sollte fundierte Kenntnisse der nationalen und internationalen regulatorischen Anforderungen besitzen und Erfahrung in der Zusammenarbeit mit...


  • Bern, Bern, Schweiz CSL Vollzeit

    Job Purpose:We are seeking an experienced and skilled Regulatory Affairs professional to lead the development of regional strategies and contribute to global regulatory strategies for the Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of the Global Regulatory Affairs team, you will be responsible for submitting regulatory...


  • Muri b. Bern, Bern, Schweiz Antrimon Group AG Vollzeit

    Regulatory Affairs EngineerWir suchen einen erfahrenen Regulatory Affairs Engineer, der sich auf die Konformität unserer Produkte und das Management ihrer gesamten Lebenszyklus verantwortlich fühlt. Als Teil unseres Teams werden Sie sicherstellen, dass alle Produkte die regulatorischen Anforderungen, insbesondere im Bereich der Medizintechnik,...


  • Bern, Bern, Schweiz Post CH AG Vollzeit

    Übernahme der RolleAls Kommunikationsmanager:in für regionale Kommunikation trittst du in eine zentrale Funktion bei der Post ein. Du bist verantwortlich für die regionale Kommunikation und die Pflege von Beziehungen zu kantonalen und kommunalen Verwaltungen sowie politischen Akteuren. Deine Aufgabe besteht darin, das mediale, kantonale und kommunale...


  • Bern, Bern, Schweiz Post CH AG Vollzeit

    ÜberblickDas Kompetenzcenter Medienstelle & Regionales gibt der Post ein Gesicht und eine Stimme. Mit deinem Team baust du Brücken, pflegst Beziehungen und stärkst damit die Reputation und die Akzeptanz des Konzerns in der Medien- sowie in der regionalen Politarena.Deine RolleAls Kommunikationsspezialist:in bist du Hauptansprechperson der Post für...


  • Bern, Bern, Schweiz Post CH AG Vollzeit

    ÜberblickDas Kompetenzcenter Medienstelle & Regionales gibt der Post ein Gesicht und eine Stimme. Mit deinem Team baust du Brücken, pflegst Beziehungen und stärkst damit die Reputation und die Akzeptanz des Konzerns in der Medien- sowie in der regionalen Politarena.Deine RolleAls Kommunikationsspezialist:in bist du Hauptansprechperson der Post für...