Regulatory Affairs Manager

1 month ago


Kimberley, Northern Cape, South Africa Unique Personnel Ltd Full time
Job Title: Senior Regulatory Affairs Manager

Unique Personnel Ltd is seeking a highly skilled Senior Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and providing superior regulatory services to our stakeholders.

Key Responsibilities:
  • Manage work streams for assigned portfolios and report on progress
  • Assist with internal and external product queries from relevant departments and stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submissions to ensure timelines, accuracy, and compliance
  • 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 data gaps are addressed
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines
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 deliver to quality, time, and cost standards
What We Offer:
  • Opportunity to work with a dynamic and growing company
  • Competitive salary and benefits package
  • Professional development and growth opportunities


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