Johannesburg: Senior Regulatory Affairs Pharmacist posted by OttoBauthentic

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.