Regulatory Affairs Specialist

2 weeks ago


Midrand, Gauteng, South Africa Hire Resolve Full time

Key Responsibilities:


As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. This includes leading, managing, and executing strategic direction, ensuring regulatory documentation meets relevant requirements, and providing input to the regulatory strategy in line with business objectives.



Key Requirements:


To be successful in this role, you will need a B. Pharm degree, registration with the South African Pharmacy Council, and a minimum of 10 years of experience in Regulatory Affairs with human medicine and biologicals experience. You will also need knowledge of regulations, acts, and guidelines for South Africa and East Africa.



Key Skills:


In addition to your technical skills, you will need to be proficient in Microsoft Office Suite and have familiarity with ZAZIBONA processes and eCTD submissions. You will also need to be competent and experienced in eCTD submissions and have a strong understanding of QA processes, APQRs, customer complaints, and pharmacovigilance experience.




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