Regulatory Strategy Manager
vor 3 Wochen
Job Purpose:
We are seeking an experienced and skilled Regulatory Affairs professional to lead the development of regional strategies and contribute to global regulatory strategies for the Cardio-Renal Therapeutic Area in the Intercontinental Region. As a key member of the Global Regulatory Affairs team, you will be responsible for submitting regulatory applications and change applications to obtain Health Authority approval in the most efficient manner. You will ensure compliance with regional regulatory requirements, manage issues, and foster effective working relationships with Global and Local Regulatory Teams, as well as other key partners.
Main Responsibilities:
- You will ensure compliance with CSL's Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
- You will serve 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 Health Authority questions, and participate in Scientific Advice Meetings.
- You will report to the Global Regulatory Affairs Head, Region Intercontinental.
- This position is based in a global company.
Qualifications:
- You hold a degree in Biological or Medical Science or Pharmacy (preferably with a post-graduate qualification). A degree in Drug Regulatory Affairs is advantageous.
- You have 10+ years of regulatory experience with a strong understanding of scientific principles and familiarity with GMP, GCP, and GLP.
- You possess demonstrated leadership, adaptability, and excellent communication skills.
Our Benefits:
We prioritize your well-being and encourage you to make it a priority.
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