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
- 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
Associate Director - Regulatory Affairs
