Ass. Director, GRA Regional TA Lead

vor 1 Woche


Bern, Bern, Schweiz CSL Behring Vollzeit
Job Purpose:

We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to obtain Health Authority (HA) approval in the fastest way. You will ensure compliance with regional regulatory requirements, manage issues, and support efforts to establish effective working relationships with Global and Local Regulatory Teams, and with other important partners including from others functions.

Main Responsibilities:
  • Ensure compliance with CSL's Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
  • Be a Subject Matter Expert on regional regulatory procedures and Health Authority (HA) requirements.
  • Develop regional regulatory strategies, participate in GRA Strategy Team (GRAST) meetings, and contribute to complex project strategy documents.
  • 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 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, Bern, Schweiz CSL Behring AG Vollzeit

    Job Purpose:We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to...


  • Bern, Bern, Schweiz Universität Bern Universität Bern Vollzeit

    Associate or Ass. Prof. tenure track in Experimental Climate and Environmental Physics & Director of the High Altitude Research Stations Jungfraujoch and Gornergratin the field of atmospheric trace gas observations (100%):Division for Climate and Environmental Physics (CEP) of the Physics Institute, University of Bern.


  • Bern, Bern, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkRegional/Local Regulatory Head LBDOur client, a large pharmaceutical organization, is looking for a Regional/Local Regulatory Head for a 12-month contract (with possibility of extension) in Bern.Responsibilities: Support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region...


  • Bern, Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For our client we are looking for a Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant) (m/f/d) 100% Tasks & Responsibilities:Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.Align all regulatory activities with regional and global...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Responsibilities: The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead / PV Auditor is responsible for leading and coordinating the Global PVRQA activities in the respective region (Americas, Asia-Pacific (APAC), European Economic Area (EEA), ECI) under the general direction of the PVRQA Regional Head, to ensure that CSL's (CSL Behring / CSL...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Responsibilities: The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead / PV Auditor is responsible for leading and coordinating the Global PVRQA activities in the respective region (Americas, Asia-Pacific (APAC), European Economic Area (EEA), ECI) under the general direction of the PVRQA Regional Head, to ensure that CSL's (CSL Behring / CSL...


  • Bern, Bern, Schweiz Foreign & Commonwealth Office Vollzeit

    Job Description (Roles and Responsibilities) 1Who are we?The British Embassy in Berne is part of a worldwide network representing British political, economic, and consular interests overseas. Together with the Department for Business and Trade in Europe we are looking for a Country Director to lead the DBT team in Switzerland (& Liechtenstein).Under the...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    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, haematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.Global Regulatory Affairs is...

  • Regional Directorin

    vor 1 Woche


    Bern, Bern, Schweiz Vebego Services Vollzeit

    Regional Director*in (m/w/d)- Arbeitsort:- Bern- Pensum: %- Arbeitsbeginn: - Abteilung:- Kaufmännische Berufe / Marketing / ITDeine Aufgaben- Gesamtverantwortung für die Niederlassung Bern, sprich die qualitative, organisatorische und finanzielle Verantwortung aller Mandate im Bereich Facility Service- Führung, Förderung und zielgerichtete Entwicklung...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    The OpportunityIf you're someone who enjoys fostering relationships, driving collaboration, and ensuring positive outcomes, then the role of Regional Lead, Legal Services EMEA is perfect for you. You'll be focusing on creating engaging experiences during the contracting process, promoting transparency, and ensuring mutual benefits for everyone involved. This...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    The OpportunityAs the Regional Lead for the Enterprise Contracting Center EMEA, you'll contribute to fostering meaningful relationships and driving collaboration across all levels of the organization and with external partners. Your focus will be creating a positive and engaging experience throughout the contracting process, ensuring agreement, transparency,...


  • Bern, Bern, Schweiz CSL Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery.The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery.The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...


  • Bern, Bern, Schweiz CSL Vollzeit

    The Opportunity As the Regional Lead for the Enterprise Contracting Center EMEA, you'll play a key role in fostering relationships and driving collaboration across all levels of our organization and with our external partners. Your mission will be to create a positive and engaging experience throughout the contracting process, ensuring agreement,...

  • Director, Finance BP

    vor 1 Woche


    Bern, Bern, Schweiz Canton de Vaud Vollzeit

    The Opportunity:Reporting to the Vice President, R&D Finance and Business Planning & Evaluation, as the Director, Finance BP - Alliances & Post Deal Management, you will have a number of external strategic alliances with external parties that are often driven through business development and licensing activities. You will provide finance support during the...

  • Director, Finance BP

    Vor 2 Tagen


    Bern, Bern, Schweiz CSL Behring AG Vollzeit

    The Opportunity:Reporting to the Vice President, R&D Finance and Business Planning & Evaluation, as the Director, Finance BP - Alliances & Post Deal Management, you will have a number of external strategic alliances with external parties that are often driven through business development and licensing activities. You will provide finance support during the...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...