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Ass. Director, GRA Regional TA Lead
vor 1 Woche
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
- 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.
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 BehringCSL 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 usAs 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-
Ass. Director, GRA Regional TA Lead
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Bern, Bern, Schweiz CSL Behring AG VollzeitJob 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...
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