Senior Regulatory Affairs Pharmacist

Description:

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

Requirements:

Qualification:
University degree (B. Pharm)
Skills & Experience:
1 – 2 years experience in pharmaceutical regulatory affairs (SADC, EAC preferred)
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.
Ability to work independently
Ability to follow instructions
Excellent computer skills (Microsoft word, adobe, excel)
Ability to produce high quality documents.