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Regulatory Affairs Specialist

1 week ago

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

The Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. This role is responsible for managing work streams, reporting on assigned portfolios of products, and establishing regulatory priorities.

Main Responsibilities
  • Manage internal product queries from relevant departments and external product queries from regulatory agencies.
  • Establish regulatory priorities and allocate resources and workloads.
  • Review regulatory agency submissions to ensure timelines, accuracy, comprehensiveness, and compliance with regulatory standards.
  • Coordinate and submit new product applications in South Africa and other applicable territories.
Requirements
  • Bachelors Degree in Pharmacy, Diploma in Pharmacy, and registration with the South African Pharmacy Council.
  • At least 5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices.
  • Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
Key Skills
  • Sound project management capabilities.
  • Proven ability to consistently deliver to quality, time, and cost standards.
  • Good Manufacturing Practices (GMP).
  • Pharmaceutical production experience or exposure to supplement regulatory knowledge.