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Regulatory Affairs Specialist

1 week ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time

Job Overview

We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. In this role, you will be responsible for ensuring compliance with regulatory requirements for human medicines and medical devices.

About the Role

This is an exciting opportunity for a qualified pharmacist to leverage their expertise in regulatory affairs to drive end-to-end regulatory activities. You will work closely with cross-functional teams to develop, commercialize, and maintain products in compliance with regulatory standards.

Key Responsibilities

  • Develop and implement regulatory strategies for human medicines and medical devices;
  • Maintain strong relationships with regulatory authorities and stakeholders;
  • Conduct risk assessments and ensure compliance with Good Manufacturing Practices (GMP);
  • Collaborate with product development and commercialization teams to ensure seamless product lifecycle management;
  • Demonstrate sound project management capabilities to deliver high-quality results on time and within budget;
  • Analyze and interpret regulatory data to inform business decisions.

Requirements

  • Bachelor's degree in Pharmacy or equivalent qualification;
  • 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;
  • Proven track record of delivering quality results in a fast-paced environment;
  • Strong communication and interpersonal skills;
  • Able to work independently and as part of a team;
  • Familiarity with pharmaceutical production processes and regulatory requirements.