Senior Regulatory Affairs Pharmacist

OttoBauthentic; Johannesburg; On-site; ZAR 300 000 - 500 000; Full time

Job summary

A pharmaceutical company in Johannesburg seeks a Regulatory Affairs Specialist to handle medicines registration and product license maintenance. The ideal candidate holds a B. Pharm degree and has 3-5 years of regulatory affairs experience, preferably in the SADC or EAC region. Responsibilities include submitting applications to health authorities and ensuring compliance with relevant legislation and guidelines. Excellent computer skills are essential for this role.

Qualifications

• 3-5 years experience in pharmaceutical regulatory affairs (SADC, EAC preferred).
• Ability to produce high quality documents.
• Ability to follow instructions.

Responsibilities

• Evaluate the dossier or variation documents and complete a gap analysis.
• Submit the application to the Health Authority.
• Review the impact of planned changes on registrations.

Skills

Knowledge of relevant medicine legislation and guidelines

Excellent computer skills

Ability to read regulatory authority guidelines

Ability to work independently

Education

B. Pharm Degree

Tools

Microsoft Word

Adobe

Excel

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.