Specialist RA Pharmacist

Minimum 5 years’ experience in a Regulatory Affairs environment with at least 2 years Pharmaceutical industry experience, including compilation and submission of new product applications.
A solid understanding of The Medicines and Related Substance Act as well as comprehensive knowledge of SAHPRA Guidelines.
Proven ability to do thorough peer review of New Product, RFI and Variation submissions, mentor junior staff and provide technical expertise and guidance.
Knowledge of principles governing regulatory requirements such as ICH and WHO technical knowledge of the CTD, eCTD and project management principles.