Regulatory Affairs Pharmacist

The opportunity
We are currently recruiting for a Regulatory Affairs Pharmacist to join our Regulatory Affairs team in South Africa on a Full Time, Permanent basis.

How youll spend your day

• Assist with the submission of new product applications in South Africa and Sub-Saharan Africa
• Submit responses to new product and backlog application resolution letters from SAHPRA and Sub-Saharan African regulatory authorities
• Submit product variation or amendment applications in accordance with the relevant legislation, regulations and guidelines in South Africa and Sub-Saharan Africa
• Ensure approval of new product submissions and amendments
• Creation, review and approval of artwork and printed packaging
• Review and approval of promotional material
• Establish and maintain effective relationships with all internal stakeholders
• Establish and maintain effective relationships with external stakeholders
• Maintain regulatory systems/programs and tracking as required locally and by global.
• Support other key functions within the business (supply chain, QA, marketing etc.)
• Remain abreast of new legislation, guidelines and developments impacting on the regulatory environment

Your experience and qualifications

• You will hold a B. Pharm degree and be registered with the South African Pharmacy Council as a practicing pharmacist
• You will have a minimum of 3 years regulatory affairs experience - preferably working with Sub-saharan African countries
• You will have good knowledge of artwork processes and approvals as well as e-CTD and e-submissions
• Experience working with innovator and/or generic products is an advantage
• You will be a self-motivated and proactive individual with good analytical and project management skills
• Above all, you will be a great team player who works collaboratively and cross functionally when required

Reports To
Associate Director - Regulatory Affairs