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Regulatory Compliance Specialist

2 months ago

Midrand, Gauteng, South Africa The Globevest Group Full time
Job Title: Regulatory Affairs Manager

The Regulatory Affairs Manager will be responsible for ensuring seamless product registration and dossier maintenance in the SEA Cluster. This role requires expertise in regulatory compliance, QA processes, and pharmacovigilance.

Main Responsibilities:

  • Lead strategic direction for regulatory affairs
  • Ensure regulatory documentation meets requirements
  • Provide input to regulatory strategy
  • Manage safety updates and CMC/ P&A updates
  • Handle license renewals and manage internal and external audits
  • Responsible for updates of dossiers and PI/PIL
  • Manage product complaints and deviations
  • Ensure regulatory compliance and quality-related records
  • Coordinate product recall or market withdrawal
  • Obtain and distribute updated information on domestic and international laws
  • Report ADRs and conduct pharmacovigilance training
  • Oversee implementation and maintenance of QMS

Requirements:

  • Grade 12
  • B. Pharm
  • Registration with the South African Pharmacy Council
  • Minimum 10 years of experience in Regulatory Affairs
  • Product registration and dossier maintenance
  • Pharmacovigilance experience and knowledge of SAHPRA submission portals
  • Launch procedures for new products
  • QA processes, APQRs, customer complaints
  • Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa