Hire Resolve
Job Details
Division
Supply chain & Manufacturing
Minimum experience
Mid-Senior
Company primary industry
Pharmaceuticals
Job functional area
Operations
Salary
R900 000 – R1 000 000 per annum
Job Description
Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client’s team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.ResponsibilitiesPrepare and submit regulatory applications for the registration of pharmaceutical productsReview and analyze regulatory documentation for accuracy and completenessDevelop and maintain relationships with regulatory authoritiesStay updated on changes in regulatory requirements and guidelinesProvide regulatory guidance and support to cross-functional teamsEnsure compliance with relevant regulations and standardsParticipate in regulatory audits and inspectionsManage the maintenance and renewal of product registrationsProvide training on regulatory compliance and best practicesConduct regulatory impact assessments for product changes and updatesCollaborate with global regulatory teams on international registration projectsRequirements:B. Pharm (Bachelor of Pharmacy)Registration with the South African Pharmacy Council (SAPC)Minimum 5 years’ experience in Regulatory Affairs (must have experience with human medicine and biologicals)Experience in product registration (NCE)Maintenance of dossiers and updatesPharmacovigilance experience/knowledge of collecting and reportingKnowledge of SAHPRA submission portalsLaunch procedures for new productsKnowledge and experience regarding QA processes, APQRs, customer complaints, etc.In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle managementKnowledge of the Marketing CodeSystems knowledgeCompetent and experienced in eCTD submissionsProficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate levelFamiliarity with ZAZIBONA processesContact Hire Resolve for your next career-changing move.Salary: negotiable.Our client is offering a highly competitive salary for this role based on experience.Apply for this role today, contact Miné Roux at Hire Resolve or on LinkedInYou can also visit the Hire Resolve website: hireresolve.us or email us your CV: [email protected]Alternatively, apply via our portal and email [email protected] We will contact you telephonically in 3 days should you be suitable for this vacancy. If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.
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