Regulatory affairs Manager

Hiring: Regulatory Affairs Manager Location: 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 Responsibilities Regulatory 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. 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

Location: Johannesburg, ZA

Posted Date: 10/8/2024