Job Description
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
RESPONSIBILITIES
- 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
QUALIFICATIONS & EXPERIENCE
- B. Pharm Degree
- 3-5 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.
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