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Pharmaceutical Product Registrar

3 weeks ago

Johannesburg, Gauteng, South Africa Unique Personnel Ltd Full time
Job Summary
We are seeking an experienced Senior Regulatory Affairs Pharmacist to join our team in the registration and maintenance of product licenses with various Health Authorities in Africa. The successful candidate will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key Responsibilities
The Senior Regulatory Affairs Pharmacist will be responsible for the following key areas:
• Submission of new pharmaceutical products for registration
• Renewals of pharmaceutical products
• Maintenance of registrations
• Evaluation of dossiers or variation documents and completion of a gap analysis
• Compilation of applications for submission in accordance with the requirements prescribed by the Health Authority (HA)
• Creation of electronic copies of applications and submission to the HA
• Attendance to subsequent correspondence from the HA to address any requests for additional information within specified deadlines
• Update of product records/databases in line with good documentation practices and company requirements
• Review of the impact of planned changes on registrations
• Review of printed packaging for compliance with legislated requirements in all affected markets
• Review of marketing material in compliance with the marketing code and country-specific regulatory requirements

Requirements
The ideal candidate should possess a University degree (B. Pharm) and have at least 2 years of experience in pharmaceutical regulatory affairs, preferably in the SADC or EAC region. The candidate should have knowledge of relevant medicine legislation and guidelines, as well as excellent computer skills (Microsoft Word, Adobe, Excel).

About Us
Unique Personnel Ltd is a leading pharmaceutical company committed to delivering high-quality medicines to the market. We are looking for a skilled Regulatory Affairs professional to join our team and contribute to our success.