Regulatory Affairs Manager
2 weeks ago
Curiska 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 requirements, update dossiers, and develop SOPs.
- Manage safety updates, CMC/P&A variations, and license renewals with authorities.
- Conduct internal and external audits.
- Report and follow up on ADRs, provide local staff training, and implement the Quality Management System.
- Ensure adherence to environmental regulations and handle product recalls, manage complaints, and stay updated on laws and regulations.
- Bachelor of Pharmacy (B. Pharm) and SAPC registration.
- At least 10 years of experience 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.
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Regulatory Affairs Manager
2 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 Manager
1 month 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:Regulatory Strategy: Develop and implement regulatory strategies and documentation to ensure...
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Regulatory Affairs Manager
1 month 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:Regulatory Strategy: Develop and implement regulatory strategies and documentation to ensure...
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Regulatory Affairs Director
2 weeks ago
Johannesburg, Gauteng, South Africa Fusion Personnel Full timeRegulatory Affairs ManagerFusion Personnel is seeking a highly skilled Regulatory Affairs Manager to lead our product registration process and ensure seamless dossier maintenance in the Southern and Eastern Africa Region.Key Responsibilities:Develop and execute strategic direction for regulatory affairs in the regionManage Chemistry Manufacturing and...
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Regulatory Affairs Specialist
1 month ago
Johannesburg, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs ManagerHire Resolve is seeking a seasoned Regulatory Affairs Manager with expertise in Human Medicine and Biologicals to join our client's dynamic team. In this role, you will be responsible for overseeing regulatory submissions and compliance of pharmaceutical products, ensuring adherence to local and international regulations.Key...
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Regulatory Affairs Specialist
4 weeks ago
Johannesburg, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs Manager Job DescriptionHire Resolve is seeking a seasoned Regulatory Affairs Manager to lead our client's dynamic team in managing regulatory submissions and compliance for human medicine and biologicals.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with local and international regulations.Prepare...
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Regulatory Affairs Specialist
3 weeks ago
Johannesburg, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs Manager Job DescriptionHire Resolve is seeking a seasoned Regulatory Affairs Manager to lead our client's dynamic team in managing regulatory submissions and compliance for human medicine and biologicals.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with local and international regulations.Prepare...
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Regulatory Affairs Pharmacist
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Johannesburg, Gauteng, South Africa The Vine Partners Full timeRegulatory Affairs PharmacistWe are seeking a skilled Regulatory Affairs Pharmacist to join our client's team at The Vine Partners.About the Role:The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards, and overseeing submissions to regulatory authorities like...
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Regulatory Affairs Specialist
4 weeks ago
Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full timeRegulatory Affairs Manager Job DescriptionCuriska (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:Regulatory Strategy: Develop and implement regulatory strategies and...
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Regulatory Affairs Specialist
4 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeJob Title: Regulatory 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:Regulatory Strategy: Lead and manage regulatory strategies and documentation.Documentation:...
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Regulatory Affairs Director
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Johannesburg, Gauteng, South Africa Hire Resolve Full timeJob SummaryHire Resolve is seeking a seasoned Regulatory Affairs Manager to join our client's team. As a key member of the organization, you will be responsible for ensuring compliance with local and international regulations, managing regulatory submissions, and overseeing all regulatory affairs activities related to human medicine and biologicals.Key...
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Regulatory Affairs Director
2 weeks ago
Johannesburg, Gauteng, South Africa Fusion Personnel Full timeRegulatory Affairs ManagerAt Fusion Personnel, we are seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance for the Southern and Eastern Africa Region.Key Responsibilities:Manage Chemistry Manufacturing and...
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Regulatory Affairs Specialist
2 weeks ago
Johannesburg, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs Manager - Human Medicine and BiologicalsHire Resolve is seeking a seasoned Regulatory Affairs Manager with expertise in Human Medicine and Biologicals to join our client's dynamic team. In this role, you will be responsible for overseeing the regulatory submissions and compliance of pharmaceutical products, ensuring adherence to local and...
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Regulatory Affairs Specialist
3 weeks ago
Johannesburg, Gauteng, South Africa Ultra Personnel Full timeJob Title: Regulatory Affairs PharmacistUltra Personnel is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical products in South Africa and other applicable territories.Key Responsibilities:Ensure timeous...
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Regulatory Affairs Director
2 months ago
Johannesburg, Gauteng, South Africa Curiska Full timeJob Description**About the Role**Curiska 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 ResponsibilitiesRegulatory Strategy: Develop and implement regulatory strategies and documentation to ensure...
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Regulatory Affairs Pharmacist Specialist
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Johannesburg, Gauteng, South Africa The Vine Partners Full timeRegulatory Affairs Pharmacist OpportunityWe are seeking a skilled Regulatory Affairs Pharmacist to join our team at The Vine Partners. The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards, and overseeing submissions to regulatory authorities.Key Qualifications...
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Regulatory Affairs Pharmacist Specialist
1 month ago
Johannesburg, Gauteng, South Africa The Vine Partners Full time{"title": "Regulatory Affairs Pharmacist", "description": "Job SummaryWe are seeking a skilled Regulatory Affairs Pharmacist to join our client\u2019s team at The Vine Partners. The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards, and overseeing submissions...
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Regulatory Affairs Professional
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Johannesburg, Gauteng, South Africa Humankind Group Full timeKey Responsibilities:We are seeking a highly skilled Regulatory Affairs Professional to join our team at Humankind Group. The ideal candidate will have a strong background in financial services, with a minimum of 7 years of experience in a related field.Requirements:7+ years of experience in financial servicesB.Com LLB degreeAdmitted attorney and Certified...
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Regulatory Affairs Specialist
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Johannesburg, Gauteng, South Africa Ultra Personnel Full timeJob Title: Regulatory Affairs PharmacistUltra Personnel is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key 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...
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Regulatory Affairs Specialist
1 week ago
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...