Regulatory Affairs Manager

1 day ago


Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.

Key Responsibilities:
  • Lead and manage regulatory strategies and documentation.
  • Ensure compliance with regulatory requirements, update dossiers, and develop SOPs.
  • Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.
  • Manage internal and external audits.
  • Report and follow up on ADRs; provide local staff training.
  • Implement and maintain the Quality Management System, identify improvements, and provide training.
  • Ensure adherence to environmental regulations.
  • Handle product recalls, manage complaints, and stay updated on laws and regulations.
Requirements:
  • Bachelor of Pharmacy (B. Pharm) and SAPC registration.
  • At least 10 years in Regulatory Affairs with human medicine and biologicals.
  • Proficient in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite. Knowledge of ZAZIBONA and eCTD submissions is essential.
  • Detail-oriented, adaptable, organized, and a strong communicator.
Compensation:

The estimated annual salary for this position is approximately R1,200,000 - R1,500,000 based on industry standards and market conditions in Midrand, South Africa.



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