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