Regulatory Affairs Manager
Job Description
Hiring: Regulatory Affairs ManagerLocation: Midrand, South AfricaAs a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key ResponsibilitiesRegulatory Strategy: Lead and manage regulatory strategies and documentation.Documentation: Ensure compliance with regulatory requirements, update dossiers, and develop SOPs.Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.Audits: Manage internal and external audits.Pharmacovigilance: Report and follow up on ADRs; provide local staff training.QMS: Implement and maintain the Quality Management System, identify improvements, and provide training.Environmental Compliance: Ensure adherence to environmental regulations.Additional Duties: Handle product recalls, manage complaints, and stay updated on laws and regulations.RequirementsEducation: Bachelor of Pharmacy (B. Pharm) and SAPC registration.Experience: At least 10 years in Regulatory Affairs with human medicine and biologicals.Skills: Proficient in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite. Knowledge of ZAZIBONA and eCTD submissions is essential.Personal Qualities: Detail-oriented, adaptable, organized, and a strong communicatorIf you are interested, please send your CV to info@curiska.co.za
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Job Detail
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Job IdJD1354181
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationJohannesburg, Gauteng, South Africa
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EducationNot mentioned