Regulatory Affairs Specialist
3 weeks ago
Key Responsibilities:
- Ensure timely initiation and management of the registration process for new product submissions
- Ensure approval of registration applications of all medicines with the relevant authorities
- Complete specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory Authority
- Ensure that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations
- Ensure that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements
- Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines
- Receive, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority
- Complete dossier audits of Registered Products for the assigned products
- Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company objectives
Core Competencies:
- Attention to detail
- Knowledge of the Regulatory requirements for medical products in South Africa and other applicable territories
- 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
- Problem solving and decision-making skills
- Sound project management capabilities
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