Regulatory Advisor

15 hours ago


Cape Town, Western Cape, South Africa MENARINI Group Full time

MENARINI Group is seeking a Regulatory Advisor to join our Medical Affairs team. As a Regional Medical Advisor, you will be accountable for implementing Medical and Scientific Affairs plans in the business area of responsibility.

This role contributes to the collective Medical & Scientific Affairs implementation team of A. Menarini product portfolio (excluding Relife portfolio) by ensuring adherence to the highest scientific, regulatory, and ethical standards.

  • Develop medically sound, feasible study protocols, CRF, budget, and site training material.
  • Perform the Triage of all safety information and medical reviewing of all ICSRs, following current procedures.
Main Responsibilities:
  • Carry out duties according to relevant SOPs/Working Instructions/Policies as well as to applicable regulations and guidelines.
  • Duly manage all documents/information regarding Pharmacovigilance in order to keep completeness, traceability, and confidentiality up to the transfer to the Archive.


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