Regulatory Affairs Specialist
2 weeks ago
A highly skilled Regulatory Affairs professional is required to lead our team and ensure compliance with regulatory requirements. The successful candidate will have a strong background in pharmaceutical regulations, excellent communication skills, and the ability to work effectively in a fast-paced environment.
Job Overview:The Regulatory Affairs Manager will be responsible for ensuring that all products are submitted to the relevant authorities in a timely manner, while also maintaining accurate records and updating existing registrations as necessary. Key responsibilities include managing work streams, reporting on assigned portfolios, and reviewing submissions to ensure accuracy and compliance.
Requirements:- Bachelor's degree in Pharmacy or equivalent registration with the South African Pharmacy Council
- Minimum 5 years' experience in Regulatory Affairs, preferably in human medicines
- Experience in use of CTD software builder and compilation of eCTD application will be an advantage
- Sound project management capabilities
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