Regulatory Affairs Manager
2 months ago
Curiska (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 compliance with regulatory requirements.
- Documentation: Update dossiers and develop SOPs to maintain compliance with regulatory requirements.
- Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.
- Audits: Manage internal and external audits to ensure compliance with regulatory requirements.
- Pharmacovigilance: Report and follow up on ADRs, and provide local staff training on pharmacovigilance requirements.
- QMS: Implement and maintain the Quality Management System, identify improvements, and provide training to staff.
- Environmental Compliance: Ensure adherence to environmental regulations and identify areas for improvement.
- Education: 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 communicator.
-
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...
-
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...
-
Regulatory Affairs Manager
2 months 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...
-
Regulatory Affairs Director
4 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...
-
Regulatory Affairs Expert
2 weeks ago
Johannesburg, Gauteng, South Africa The Vine Partners Full timeJob Title: Regulatory Affairs PharmacistLocation: Johannesburg, GautengSalary: R62,000 - R67,000 per monthAbout the Role:We are seeking a skilled Regulatory Affairs Pharmacist to manage the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards and overseeing submissions to regulatory authorities like SAHPRA and other...
-
Regulatory Affairs Specialist
2 months 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...
-
Regulatory Affairs Specialist
1 month 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...
-
Regulatory Affairs Specialist
1 month 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...
-
Regulatory Affairs Pharmacist
1 month ago
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...
-
Regulatory Affairs Specialist
1 month 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...
-
Regulatory Affairs Specialist
1 month 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:...
-
Regulatory Affairs Expert
1 week 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...
-
Regulatory Affairs Director
2 months ago
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...
-
Regulatory Affairs Director
4 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...
-
Regulatory Affairs Specialist
4 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...
-
Regulatory Affairs Specialist
1 month 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...
-
Regulatory Affairs Manager Lead
2 weeks ago
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...
-
Regulatory Affairs Specialist
1 week ago
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 /...
-
Regulatory Affairs and Compliance Lead
1 week ago
Johannesburg, Gauteng, South Africa Network Recruitment Full timeJob Title: Regulatory Affairs and Compliance LeadJob Description:We are seeking a highly skilled Regulatory Affairs and Compliance Lead to join our team at Network Recruitment. This is a challenging role that requires a strong understanding of regulatory affairs and compliance in the financial services industry.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Specialist
2 weeks ago
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...