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Regulatory Affairs Lead

2 weeks ago


Pretoria, Gauteng, South Africa MNA Recruitment Full time

Job Summary

MNA Recruitment seeks a highly skilled Regulatory Affairs Manager to lead the regulatory team in providing superior services to relevant departments and external partners.

Key Responsibilities:

  1. Manage work streams for assigned portfolios and report on progress.
  2. Assist with internal product queries from relevant departments.
  3. Assist with external product queries from SAHPRA, other MRA's, and third-party stakeholders.
  4. Establish regulatory priorities and allocate resources and workloads.
  5. Review regulatory agency submissions to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.
  6. Coordinate and submit new product applications in South Africa and other applicable territories.

Requirements:

  1. Bachelor's degree in Pharmacy or Diploma in Pharmacy with registration from the South African Pharmacy Council.
  2. Minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines.
  3. Experience in using CTD software builder and compilation of eCTD application is an advantage.
  4. Sound project management capabilities.
  5. Proven ability to deliver quality results under time and cost constraints.