Regulatory Affairs Specialist

1 day ago


Pretoria, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time
Job Title: Regulatory Affairs Manager

MNA Recruitment (Pty) Ltd is seeking a highly skilled Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements and providing superior regulatory services to relevant departments within the company and with external partners and principals.

Key Responsibilities:
  • Manage work streams for assigned portfolios and report on progress
  • Assist with internal product queries from relevant departments and 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, and compliance with regulatory standards
  • Coordinate and submit new product applications in South Africa and other applicable territories
Requirements:
  • Bachelor's degree in Pharmacy or Diploma in Pharmacy and registration with the South African Pharmacy Council
  • Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines
  • Demonstrable experience across the product development, commercialization, and maintenance lifecycle
  • Sound project management capabilities and proven ability to consistently deliver quality, time, and cost standards
What We Offer:
  • A competitive salary and benefits package
  • Opportunities for professional growth and development
  • A dynamic and supportive work environment


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