Regulatory Pharmacist

Regulatory Pharmacist
Company:

Hr Studio (Pty) Ltd


Regulatory Pharmacist

Details of the offer

Were looking for A Regulatory Pharmacist to be responsible for ensuring that the Companys health & wellness products comply with all South African legislation as well as SADC countries legislation as well as all new product development within the division. Who are you? Passion for health and wellness in general; Passion for changing peoples lives for the best with health and wellness products; Passion for research of new health and wellness products. What the role? You will be responsible for: Compiling product dossiers for all CAMS product in the applicable countries, i.e. South Africa, Botswana, Mozambique and possibly Namibia. Ensuring approval of registration of all CAMS product in the applicable countries. Reviewing and approving all material for labels, the monthly catalogue, digital media and training material for the field, ensuring compliance with SAHPRA legislation and the SA code of Marketing practice. Reviewing all current and new product formulations, packaging and label claims and making suggestions for improvement and compliance. Assist with the sourcing of information and documentation required for new product launches including the Product Launch brief. Undertake the task of compiling PIs and PILs, i.e. patient leaflets, for all existing products as well as for new launches. Responsible for audits and inspections at third party manufacturers to ensure compliance with GMP. NPD projects. Keep abreast of changes to the relevant legislation and attend workshops and meetings related to the Industry. Managing the QA and QC function. Boxes to tick B. Pharm degree. Registered with SAPC as a practising Pharmacist. At least three years experience in the Regulatory Affairs department of a CAMS company NPD experience in the CAMS industry would be an advantage. You are someone who has Good analytical ability; Excellent technical and industry knowledge; Attention to detail Skilled in fact-finding Great research ability Good organizational skills ; Strong interpersonal skills; Able to work independently and with minimal supervision; Able to work well in a team environment ; Good communication (written & verbal) and interpersonal skills; Possess a high standard of quality orientation; Possess integrity, tenacity and are able to use your initiative.


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