Regulatory Affairs Manager

2 months ago


Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full time
Regulatory Affairs Manager

Curiska (Pty) Ltd 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:
  • Regulatory Strategy: Develop and implement regulatory strategies and documentation to ensure compliance with regulatory requirements.
  • Documentation: Update dossiers and develop SOPs to maintain compliance with regulatory requirements.
  • Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.
  • Audits: Manage internal and external audits to ensure compliance with regulatory requirements.
  • Pharmacovigilance: Report and follow up on ADRs, and provide local staff training on pharmacovigilance requirements.
  • QMS: Implement and maintain the Quality Management System, identify improvements, and provide training to staff.
  • Environmental Compliance: Ensure adherence to environmental regulations and identify areas for improvement.
Requirements:
  • Education: Bachelor of Pharmacy (B. Pharm) and SAPC registration.
  • Experience: At least 10 years in Regulatory Affairs with human medicine and biologicals.
  • Skills: Proficient in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite. Knowledge of ZAZIBONA and eCTD submissions is essential.
  • Personal Qualities: Detail-oriented, adaptable, organized, and a strong communicator.


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