Senior Regulatory Affairs Specialist

4 days ago


Midrand, Gauteng, South Africa Emporium Human Capital Full time
Job Summary

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Emporium Human Capital. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for human medicines and medical devices.

Key Responsibilities
  • Manage work streams for internal and external product queries, regulatory agency submissions, and compliance with regulatory standards.
  • Establish regulatory priorities, allocate resources, and ensure timely and accurate submission of regulatory materials.
  • Develop and implement regulatory strategies for new products, including complementary medicines and medical devices.
  • Conduct dossier due diligence, prepare registration applications, and ensure maintenance of existing registrations.
  • Collaborate with internal and external stakeholders to assess regulatory submissions requirements and ensure alignment with company values.
Requirements
  • Bachelor's Degree in Pharmacy, Diploma in Pharmacy, and registration with the South African Pharmacy Council.
  • At least 5 years of experience in Regulatory Affairs, preferably in human medicines and medical devices.
  • Strong project management skills, ability to prioritize, and high degree of complexity and change.
  • Excellent communication and negotiation skills, with ability to set standards and objectives.
  • Fluency in English.
Preferred Qualifications
  • Experience with CTD software builder and eCTD dossier applications.
  • IT skills, including Microsoft Office.
  • Active learning, strategic thinking, and complex problem-solving skills.

Emporium Human Capital is a leading recruitment agency dedicated to providing top talent to the pharmaceutical and healthcare industries. We are committed to fostering a culture of excellence, teamwork, and innovation.



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