Regulatory Affairs Manager

2 weeks ago


Johannesburg, Gauteng, South Africa Curiska Full time
Regulatory Affairs Manager

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

Key Responsibilities:
  • Develop and implement regulatory strategies and documentation.
  • Ensure compliance with regulatory requirements, update dossiers, and develop SOPs.
  • Manage safety updates, CMC/P&A variations, and license renewals with authorities.
  • Conduct internal and external audits.
  • Report and follow up on ADRs, provide local staff training, and implement the Quality Management System.
  • Ensure adherence to environmental regulations and 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 of experience 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.


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