Senior Regulatory Affairs Specialist
Vor 3 Tagen
Job Purpose:
CSL is seeking a highly experienced and skilled Regulatory Affairs Specialist to lead the development of regional strategies in the Cardio-Renal Therapeutic Area. This individual will contribute to global regulatory strategies and submit regulatory applications for development products and change applications for registered products to obtain Health Authority approval.
Main Responsibilities:
- Ensure compliance with CSL's Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
- Develop regional regulatory strategies, participate in GRA Strategy Team meetings, and contribute to complex project strategy documents.
- Coordinate submissions, responses to Health Authority questions, and participate in Scientific Advice Meetings.
- Collaborate with Global Regulatory Affairs, Head Region Intercontinental.
- This position is based in Switzerland.
Qualifications:
- Degree in Biological or Medical Science or Pharmacy (post-graduate qualification advantageous).
- 10+ years of regulatory experience, scientific principles, and familiarity with GMP, GCP, and GLP.
- Demonstrated leadership, adaptability, and excellent communication skills.
Our Work Environment:
At CSL, we prioritize our employees' well-being and offer a supportive work environment.
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