Regulatory Compliance Specialist

2 months ago


Johannesburg, Gauteng, South Africa ES Recruitment Full time
Key Responsibilities:

The successful candidate will be responsible for ensuring regulatory compliance with Act 101 and Act 53.

  • Act as Responsible Pharmacist for the entity.
  • Develop and implement regulatory strategies and plans.
  • Prepare and submit dossiers for regulatory approval.
  • Manage quality and compliance with a focus on quality management system and strategy.
  • Perform audits and inspections to ensure regulatory compliance.
  • Identify and implement corrective actions to address deviations and non-conformances.
  • Manage Pharmacovigilance and product life cycle.
  • Develop and maintain knowledge and intelligence management systems.

Requirements:

  • Must have a B. Pharm degree and be registered with the South African Pharmacy Council.
  • At least 2-3 years of regulatory experience.
  • Experience in compilation and submission of Act 101 (SAHPRA) Dossiers and Act 36 Dossiers.
  • Thorough understanding of GMP and regulatory compliance.
  • High accuracy and attention to detail skills.


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