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Regulatory Affairs Pharmacist

1 month ago

Midrand, Gauteng, South Africa Emporium Full time
Regulatory Affairs Pharmacist

Emporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.

Key Responsibilities:
  • Manage work streams for- and report on the assigned portfolio of products
  • Assist with internal product queries from relevant departments
  • Assist with external product queries from regulatory authorities and third-party stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • 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
  • Develop regulatory strategies and implementation plans for new products
  • Conduct dossier due diligence to ensure all data gaps are addressed
  • Prepare registration applications for submission to regulatory authorities
  • Collaborate with internal and external stakeholders to assess regulator's submissions requirements
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry
Requirements:
  • Bachelor's degree in Pharmacy or Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • 3 to 5 years' experience in Regulatory Affairs, preferably in human medicines
  • 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
What We Offer:
  • Competitive salary
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment

To apply for this position, please send your MS Word format CV to jobs@emporium.co.za and use POS24203 in the subject line.