Regulatory Affairs Specialist
1 month ago
Curiska (Pty) Ltd is seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.
Key Responsibilities:- Regulatory Strategy: Develop and implement regulatory strategies and documentation to ensure compliance with regulatory requirements.
- Documentation: Update dossiers and develop SOPs to maintain regulatory compliance.
- Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.
- Audits: Manage internal and external audits to ensure regulatory compliance.
- Pharmacovigilance: Report and follow up on ADRs, and provide local staff training on pharmacovigilance requirements.
- QMS: Implement and maintain the Quality Management System, identify improvements, and provide training to staff.
- Environmental Compliance: Ensure adherence to environmental regulations and standards.
- Additional Duties: Handle product recalls, manage complaints, and stay updated on laws and regulations affecting the company.
- 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 in this opportunity, please send your CV to info@curiska.co.za
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