Regulatory Affairs Manager

Hiring: Regulatory Affairs ManagerLocation: Midrand, South Africa As a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.
Key ResponsibilitiesRegulatory Strategy: Lead and manage regulatory strategies and documentation.Documentation: Ensure compliance with regulatory requirements, update dossiers, and develop SOPs.Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.Audits: Manage internal and external audits.Pharmacovigilance: Report and follow up on ADRs; provide local staff training.QMS: Implement and maintain the Quality Management System, identify improvements, and provide training.Environmental Compliance: Ensure adherence to environmental regulations.Additional Duties: Handle product recalls, manage complaints, and stay updated on laws and regulations.
RequirementsEducation: 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 If you are interested, please send your CV to ******