Ra Pharmacist

OTCThe following vacancy exists and those interested are requested to apply in writingReporting to Regulatory Affairs Managerï‚· To provide superior regulatory support and liaise with external partners and principals.ï‚· Control and manage a portfolio of products for both the South African and Export market in terms of dossier registration and maintenance.ï‚· Ensure legal compliance with the medicines and related substances Control Act and South African Pharmacy Counsel as well as the regulatory authorities in export territories.ï‚· Build and maintain working relationships with the relevant Regulatory Authorities.Job PurposeRequired Learningï‚· BPharm.ï‚· A minimum of 3 5 years Medicine Registration experience, in a Pharmaceutical Regulatory environment with dossier compilation experience.ï‚· Knowledge and experience of the regulatory requirements for medical products in South Africa and Africa.Key Job Outputs ï‚· To ensure timeous submission of variations and new product registrations in support of the wider OTC business objectives.ï‚· Co-ordination and submission of new product applications.ï‚· Co-ordination and submission of amendments for currently marketed products.ï‚· Policy transfer of MCC and SAPC regulatory authority regulations to portfolio of product dossiers.ï‚· Building and maintain effective working relationships with both the South Africa and India regulatory teams.ï‚· Assisting Provide support with internal product queries from other areas within the OTC business.ï‚· Timeous assistance (due diligence, co-ordination, review and submission of amendments) to the RA manager for managing regulatory risks of OTC product portfolio.ï‚· Build and maintain working relationships with internal and external customers.ï‚· Create and apply processes in line with best practice.ï‚· Self- Development - Attend conferences and relevant training to upskill knowledge in regulatory environment