Regulatory Affairs Pharmacist (POS24336)
Aeroton Jhb South
R 800 000 per month
Purpose: Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio 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.
Requirements Bachelors degree in Pharmacy and registered with the South African Pharmacy Council1-2 years experience in Regulatory Affairs, preferably in orthodox, human medicinesDemonstrable experience across the product development, commercialization, and life-cycle maintenance.Sound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsKnowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.Experience in use of CTD software builder and compilation of eCTD application will be an advantage such as docuBridge.Duties: Ensure timeous initiation and management of the registration process for new product submissionsEnsure approval of registration applications of all medicines with the relevant authoritiesCompletes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory AuthorityEnsures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrationsEnsures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreementsEnsure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelinesReceives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory AuthorityCompletes dossier audits of Registered Products for the assigned productsConducts 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 objectivesEstablish and maintain effective relationships with Regulatory AuthoritiesManages relationships with the Regulatory Authorities to ensure more effective streamlining of the companys applications when requiredBuilding sustainable relationships with internal and external stakeholders to achieve regulatory goalsEffectively managing, auditing and implementation of Regulatory systemsPrepare, review and adhere to Standard Operating Procedures (SOPs) and local Regulatory GuidelinesEnsure alignment of personal and company valuesTo apply for this position, please use POS 24336 RA Pharmacist as reference.