Regional Regulatory Affairs Specialist
Vor 5 Tagen
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.
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