Date | 2024-12-25 |
---|---|
Job Title | Regulatory Affairs Manager |
Employer | Curiska More Information |
Salary | 0 |
Category | Medical |
Location |
Gauteng / Johannesburg |
Job Summary
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 Curiska
Regulatory Affairs Manager position available in Gauteng, Johannesburg. This job position was posted by Curiska. The job has been posted as a premium ad on 2024-12-25 at 13:08:33 in the Medical category
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