Regional Regulatory Affairs Specialist

vor 2 Monaten


Opfikon, Zürich, Schweiz CSL Vollzeit
Job Purpose:

We are seeking an experienced Regulatory Affairs professional 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 to obtain Health Authority approval in the most efficient manner.

Main Responsibilities:
  • Ensure compliance with CSL's Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
  • Develop and maintain expertise on regional regulatory procedures and Health Authority requirements.
  • 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.
  • Report to the Global Regulatory Affairs Head, Region Intercontinental.
Qualifications:
  • Degree in Biological or Medical Science or Pharmacy (post-graduate qualification advantageous).
  • 10+ years of regulatory experience with scientific principles, GMP, GCP, and GLP familiarity.
  • Demonstrated leadership, adaptability, and excellent communication skills.
Our Offer:

We prioritize our employees' well-being and offer a supportive work environment.



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