Regulatory Affairs Strategic Manager

3 days ago


Johannesburg, Gauteng, South Africa Unique Personnel Ltd Full time

Job Description:

At Unique Personnel Ltd, we are seeking a highly skilled Regulatory Affairs Portfolio Lead to join our team. This role is responsible for managing work streams and reporting on assigned portfolios of products.

Main Responsibilities:

  • Assisting with internal product queries from relevant departments
  • Assisting with external product queries from the SAHPRA, other MRAs, and third-party stakeholders
  • Establishing regulatory priorities and allocating resources and workloads
  • Reviewing regulatory agency submissions of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Artwork reviews and approvals
  • Co-ordinating and submitting new product applications in South Africa and other applicable territories
  • Developing regulatory strategies and implementation plans for the preparation and submission of new products
  • Conducting dossier due diligence to ensure all data gaps are addressed
  • Preparing registration applications for submission to the regulatory authorities
  • Working in collaboration with internal and external stakeholders to assess regulators' submissions requirements
  • Maintaining current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry

Requirements:

  • Bachelor's degree in pharmacy/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
  • Experience in use of CTD software builder and compilation of eCTD applications
  • IT skills
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills

Estimated Salary: R850,000 - R1,200,000 per annum (depending on experience)



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