Regulatory affairs Manager

SUMMARY:
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POSITION INFO:

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

If you are interested, please send your CV to