Regulatory Affairs Manager
1 day ago
We are seeking a highly experienced Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.
Key Responsibilities:- Lead and manage regulatory strategies and documentation.
- Ensure compliance with regulatory requirements, update dossiers, and develop SOPs.
- Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.
- Manage internal and external audits.
- Report and follow up on ADRs; provide local staff training.
- Implement and maintain the Quality Management System, identify improvements, and provide training.
- Ensure adherence to environmental regulations.
- Handle product recalls, manage complaints, and stay updated on laws and regulations.
- Bachelor of Pharmacy (B. Pharm) and SAPC registration.
- At least 10 years in Regulatory Affairs with human medicine and biologicals.
- Proficient in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite. Knowledge of ZAZIBONA and eCTD submissions is essential.
- Detail-oriented, adaptable, organized, and a strong communicator.
The estimated annual salary for this position is approximately R1,200,000 - R1,500,000 based on industry standards and market conditions in Midrand, South Africa.
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Regulatory Affairs Manager
4 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeRegulatory Affairs ManagerCuriska is seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key Responsibilities:Develop and implement regulatory strategies and documentation.Ensure compliance with regulatory...
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Regulatory Affairs Manager
4 weeks ago
Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full timeRegulatory Affairs ManagerCuriska (Pty) Ltd is seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key Responsibilities:Develop and implement regulatory strategies and documentation.Ensure compliance with...
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Regulatory Affairs Expert
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Regulatory Affairs Expert
2 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeRegulatory Affairs Manager Position at CuriskaWe are seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key ResponsibilitiesRegulatory Strategy: Develop and implement regulatory strategies and...
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Regulatory Affairs Director
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Regulatory Affairs Specialist
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Regulatory Affairs Manager Lead
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Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full timeJob Title: Regulatory Affairs Manager LeadLocation: Not SpecifiedWe are seeking a highly skilled Regulatory Affairs Manager Lead to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key Responsibilities:1. Regulatory Strategy: Lead and manage regulatory strategies...
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Regulatory Affairs Specialist
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Johannesburg, Gauteng, South Africa Fusion Personnel Full timeFusion Personnel is seeking a highly skilled Regulatory Affairs Manager to ensure seamless product registration processes and dossier maintenance for the Southern and Eastern Africa Region. The ideal candidate will have management experience and be responsible for leading and executing strategic direction, managing Chemistry Manufacturing and Controls (CMC /...
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Regulatory Affairs Specialist
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Johannesburg, Gauteng, South Africa Curiska Full timeRegulatory Affairs Manager Position at CuriskaAs a key member of our team, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements. Key responsibilities include leading and managing regulatory strategies, ensuring compliance with regulatory requirements, and...
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Regulatory Affairs Director
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Johannesburg, Gauteng, South Africa Fusion Personnel Full timeFusion Personnel is seeking a seasoned Regulatory Affairs Manager to lead our team in the Southern and Eastern Africa Region. Key Responsibilities:Fundamental Requirements:MatricPharm (Bachelor of Pharmacy)South African Pharmacy Council (SAPC) registrationValid Drivers License and Own vehicle5 10 years experience in Regulatory AffairsMust have management...
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Regulatory Affairs Pharmacist Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Johannesburg, Gauteng, South Africa Hire Resolve Full timeHire Resolve is seeking a seasoned Regulatory Affairs Specialist to oversee the regulatory submissions and compliance of pharmaceutical products. This role requires expertise in Human Medicine and Biologicals, ensuring adherence to local and international regulations.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with...
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Senior Regulatory Affairs and Compliance Lead
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Johannesburg, Gauteng, South Africa Network Recruitment Full timeJob Title: Senior Regulatory Affairs and Compliance LeadJob Summary:We are seeking a highly experienced Senior Regulatory Affairs and Compliance Lead to join our team at Network Recruitment. As a key member of our organization, you will play a crucial role in overseeing regulatory submissions, ensuring compliance with all applicable laws and regulations, and...
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Johannesburg, Gauteng, South Africa Network Recruitment Full timeJoin Network Recruitment in our search for a Senior Regulatory Affairs and Compliance Specialist. As a key member of our team, you will play a vital role in ensuring our clients' regulatory submissions are compliant with all applicable laws and regulations. Your expertise will be invaluable in guiding our clients through the complex world of regulatory...
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Johannesburg, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs Manager Job DescriptionHire Resolve is seeking a highly skilled Regulatory Affairs Manager to join our client's team. This role involves managing regulatory submissions and ensuring compliance with local and international regulations for human medicine and biologicals.Key Responsibilities:Develop and implement regulatory strategies to...
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Regulatory Affairs Pharmacist
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Johannesburg, Gauteng, South Africa The Vine Partners Full timeAt The Vine Partners, we are seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Job Title: Regulatory Affairs Pharmacist - Product Compliance ExpertLocation: Johannesburg, GautengSalary: R62,000 - R67,000 per monthAbout the RoleWe require a detail-oriented professional with experience in managing regulatory aspects of product portfolios,...
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Regulatory Affairs Specialist
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Johannesburg, Gauteng, South Africa Ultra Personnel Full timeJob Description for Regulatory Affairs PharmacistKey Responsibilities:Ensure timely initiation and management of the registration process for new product submissionsEnsure approval of registration applications of all medicines with the relevant authoritiesComplete specific pre-registration activities including receipt, screening, compilation and timeous...