Regulatory Affairs Pharmacist: Portfolio Lead

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Johannesburg (Incl. Northern Suburbs) pharmaceutical-healthcare
Reporting to Regulatory Affairs Manager Job Purpose Support the Regulatory team to provide superior Regulatory support to relevant departments within the company and with external partners and Principals, and to control and manage team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications. Required Learning Bachelor of Pharmacy At least 5 years’ experience in Pharmaceutical Regulatory environment Computer literate with prior experience with MS Office and docuBridge (Preferred). Manage work streams for- and report on the assigned portfolio Co-ordination and submission of new product applications in South Africa and other applicable territories Co-ordination and submission of amendments for currently marketed products Internal training Assisting with internal product queries from relevant departments Assisting with external product queries from the MCC and third-party stakeholders Attention to detail Knowledge of the Regulatory requirements for medical products in South Africa Project management skills Leadership skills Ability to prioritise and work to tight deadlines Systems approach Cross Functional skills: Ability to network, liaise and negotiate with others Ability to set standard and objectives and monitor progress Ability to monitor a team Problem solving and decision-making skills