Regulatory Affairs Specialist

4 hours ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time
Job Title: Regulatory Affairs Pharmacist

Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.

Key Responsibilities:
  • Manage work streams for- and report on the assigned portfolio of products, ensuring timely and accurate submissions to regulatory agencies.
  • Establish regulatory priorities and allocate resources and workloads to ensure compliance with regulatory standards.
  • Review regulatory agency submissions to ensure accuracy, comprehensiveness, and compliance with regulatory standards.
  • Coordinate and submit new product applications in South Africa and other applicable territories, including the development of regulatory strategies and implementation plans.
  • Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
  • Prepare registration applications for submission to regulatory authorities, ensuring alignment with relevant legislation, regulations, and guidelines.
  • Work in collaboration with internal and external stakeholders to assess regulators' submissions requirements and ensure maintenance and/or update of existing registrations.
  • Update and maintain databases, trackers, and systems for all regulatory-related activities, ensuring Good Regulatory Practices are maintained.
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
  • Internal training and mentoring of peers when required, ensuring alignment of personal and company values.
  • Establish and maintain effective relationships with Regulatory Authorities, internal, and external stakeholders, formulating or implementing regulatory affairs systems, policies, and procedures to ensure regulatory compliance.
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, including complementary medicines and medical devices for end-to-end regulatory activities.
  • Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
  • Sound project management capabilities, proven ability to consistently deliver to quality, time, and cost standards.
  • Good Manufacturing Practices (GMP) and pharmaceutical production experience or exposure to supplement regulatory knowledge.
What We Offer:

Emporium Human Capital offers a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive remuneration package.

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