Regulatory Affairs Director

1 month ago


Johannesburg South, South Africa Emporium Full time

Lead Regulatory Affairs Professional

At Emporium, we are committed to excellence in regulatory affairs.

The position of Regulatory Affairs Manager is available for a highly skilled professional with expertise in regulatory compliance and team leadership. The role involves leading the Regulatory team to deliver superior services to relevant departments within the company and external partners, ensuring legal compliance with regulatory authorities, and managing portfolio and team outputs.

About the Role

This role requires a Bachelor's degree in Pharmacy or Diploma in Pharmacy, registration with the South African Pharmacy Council, and minimum 5 years' experience in Regulatory Affairs, preferably in human medicines. The ideal candidate will have demonstrated experience across the product development, commercialization, and maintenance lifecycle, sound project management capabilities, and proven ability to consistently deliver quality results on time and within budget.

Key Responsibilities

  • Manage work streams for assigned portfolios, report on progress, and assist with internal and external product queries.
  • Establish regulatory priorities, allocate resources, and review agency submission materials for timelines, accuracy, and compliance.
  • Develop regulatory strategies, implement plans for new product submissions, and conduct dossier due diligence to address data gaps.
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines, and ensure alignment of personal and company values.
  • Formulate or implement regulatory affairs systems, policies, and procedures to maintain regulatory compliance.

Requirements

  • Experience with CTD software builder and compilation of eCTD applications is an advantage.
  • Leadership skills, management of personnel resources, and ability to prioritize tasks under tight deadlines are essential.
  • Sound IT skills, analytical thinking, and problem-solving abilities are necessary for success in this role.

What We Offer

Employees at Emporium enjoy a competitive salary range of R1,5 - 1,7 million per annum, depending on qualifications and experience. Benefits include opportunities for career growth, professional development, and collaboration with a dedicated team. Our goal is to provide a dynamic work environment that fosters innovation, creativity, and excellence in regulatory affairs.



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