Regulatory Affairs Lead
1 month ago
Curiska is a leading organization 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.
This is a dynamic role that requires a strong regulatory background, excellent communication skills, and the ability to lead and manage regulatory strategies and documentation.
We are offering a competitive salary of R1 200 000 per annum, reflecting the high level of expertise required for this position.
The ideal candidate will have a Bachelor of Pharmacy (B. Pharm) degree and SAPC registration, as well as at least 10 years of experience in Regulatory Affairs with human medicine and biologicals.
Key responsibilities include:
- Developing and implementing regulatory strategies
- Maintaining accurate and up-to-date dossiers
- Handling safety updates and managing CMC/P&A variations
- Managing internal and external audits
- Implementing and maintaining the Quality Management System
We offer a supportive work environment, opportunities for professional growth, and a comprehensive benefits package, including medical aid, retirement funding, and annual leave.
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