Permanent - Senior Regulatory Affairs Pharmacist - Johannesburg - South Africa

Reporting to:  Regulatory Affairs Portfolio Manager – ZA Exports

Main Purpose of Job:

Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

Core Key Areas:

Submission of new pharmaceutical products for registration 

Renewals of pharmaceutical products 

Maintenance of registrations

Activities:

Evaluate the dossier or variation documents and complete a gap analysis

On receipt of additional data (if required), compile the application for submission in accordance with the requirements for such applications, prescribed by the Health Authority (HA)

Create a complete electronic copy of the application

Submit the application (with samples if required) to the HA

Attend to subsequent correspondence from the HA to address any requests for additional information within deadlines specified. 

Ensure product records/databases are updated in line with good documentation practices and company requirements.

Review the impact of planned changes on registrations 

Review of printed packaging for compliance with legislated requirements all affected markets 

Review of marketing material in compliance with the marketing code and country specific regulatory requirements

Any other task relevant to the RA department as requested by management

Qualification:

University degree (B. Pharm)

Skills & Experience:

1 – 2 years experience in pharmaceutical regulatory affairs (SADC, EAC preferred)

Must have dealt with African countries

Knowledge of relevant medicine legislation and guidelines

Ability to read regulatory authority guidelines, assimilate and interpret this data to provide accurate, succinct submissions.

Ability to argue scientifically where sufficient justification exists to request exemption from certain requirements stated in guidelines.

Must have personally handled Dossiers (full function) 

Ability to work independently

Ability to follow instructions

Excellent computer skills (Microsoft word, adobe, excel)

Ability to produce high quality documents.