Job Purpose:
We are seeking an experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental Region. You will develop regional strategies, contributing to global regulatory strategies, and submit regulatory applications for development products and change applications for registered products to obtain Health Authority approval.
Main Responsibilities:
1. Ensure compliance with CSL's Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
2. Be a Subject Matter Expert on regional regulatory procedures and Health Authority requirements.
3. Develop regional regulatory strategies, participate in GRA Strategy Team meetings, and contribute to complex project strategy documents.
4. Coordinate submissions, responses to HA questions, and participate in Scientific Advice Meetings.
5. Report to the Global Regulatory Affairs Head Region Intercontinental.
This position is based in Switzerland.
Qualifications:
1. Degree in Biological or Medical Science or Pharmacy (preferably with a post-graduate qualification). A degree in Drug Regulatory Affairs is advantageous.
2. 10+ years of regulatory experience of scientific principles, and familiarity with GMP, GCP, and GLP.
3. Demonstrated leadership, adaptability, and excellent communication skills.
Making your well-being a priority is important and so are you.