Regulatory Affairs Specialist

4 hours ago


Midrand, Gauteng, South Africa Emporium Human Capital Full time

Job Overview:

We are seeking a highly skilled and experienced Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an excellent opportunity for a motivated individual to take on a challenging role in the pharmaceutical industry.

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 timelines, accuracy, comprehensiveness, or 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 address data gaps
  • Prepare registration applications for submission to regulatory authorities
  • Collaborate with internal and external stakeholders to assess regulators' submissions requirements
  • Maintain current knowledge of relevant legislation, regulations, and guidelines pertaining to the pharmaceutical industry
  • Internal training and mentoring
  • Establish and maintain effective relationships with regulatory authorities and internal/external stakeholders
  • Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance
  • Support activities such as internal audits or regulatory agency inspections

About You:

  • 5+ years of experience in regulatory affairs, preferably in human medicines
  • Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • 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

Requirements:

  • Strong knowledge of CTD software builder and eCTD application compilation
  • Excellent IT skills and ability to prioritize tasks under tight deadlines
  • Systems and operations analysis skills
  • Basic cost management skills
  • Strategic thinking and problem-solving abilities
  • Ability to network, liaise, and negotiate with others
  • Complex problem-solving and decision-making skills

Educational Requirements:

  • Bachelor's degree in Pharmacy or Diploma in Pharmacy

Estimated Salary Range: R750,000 - R1,200,000 per annum



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