Regulatory Affairs Specialist
1 week ago
Hire 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 and submit documentation for regulatory approvals, including product registrations and license applications.
- Coordinate and liaise with regulatory authorities regarding submissions and queries.
- Review product labeling, advertising materials, and promotional content for compliance with regulations.
- Ensure ongoing compliance with post-market surveillance requirements and reporting obligations.
- Provide regulatory training and support to cross-functional teams.
- Conduct regulatory impact assessments for product changes and maintain product dossiers.
- B. Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC)
- Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience
- Skills: product registration and dossier maintenance, pharmacovigilance experience, knowledge of SAHPRA submission portals, launch procedures for new products, QA processes, APQRs, customer complaints, knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa, Microsoft Office Suite proficiency, familiarity with ZAZIBONA processes and eCTD submissions
- Family Leave (Maternity, Paternity)
- Paid Time Off (PTO) (if applicable)
Hire Resolve is committed to providing a competitive salary for this role based on experience. If you are a seasoned Regulatory Affairs Manager looking for a new challenge, please contact Miné Roux at Hire Resolve or apply through our portal.
-
Johannesburg, Gauteng, South Africa Network Recruitment Full timeJob Title: Senior Regulatory Affairs and Compliance SpecialistAs a Senior Regulatory Affairs and Compliance Specialist, you will play a crucial role in overseeing regulatory submissions, ensuring compliance with all applicable laws and regulations, and providing expert guidance on regulatory matters.Key Responsibilities:Develop and implement regulatory...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Johannesburg, Gauteng, South Africa Network Recruitment Full timeSenior Regulatory Affairs and Compliance SpecialistAs a key member of our team, you will play a vital role in ensuring our organization's compliance with all applicable laws and regulations. Your expertise will be instrumental in guiding our management team through regulatory matters, ensuring seamless interactions with regulatory agencies, and maintaining...
-
Regulatory Affairs Specialist
3 weeks 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...
-
Johannesburg, Gauteng, South Africa Network Recruitment Full timeSenior Regulatory Affairs and Compliance SpecialistNetwork Recruitment is seeking a highly skilled Senior Regulatory Affairs and Compliance Specialist to join our team. As a key member of our organization, you will play a crucial role in ensuring compliance with all applicable laws and regulations.Key Responsibilities:Regulatory Strategy Development: Develop...
-
Regulatory Affairs Specialist
1 week 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 week 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 week 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 Specialist
4 days 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...
-
Johannesburg, Gauteng, South Africa Network Recruitment Full timeJob Title: Senior Regulatory Affairs and Compliance SpecialistNetwork Recruitment is seeking a highly skilled Senior Regulatory Affairs and Compliance Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with all applicable laws and regulations, and providing expert guidance on regulatory...
-
Regulatory Affairs Pharmacist Specialist
3 weeks 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...
-
Regulatory Affairs Pharmacist
1 week 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 Manager
3 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:Regulatory Strategy: Develop and implement regulatory strategies and documentation to ensure...
-
Regulatory Affairs Manager
3 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:Regulatory Strategy: Develop and implement regulatory strategies and documentation to ensure...
-
Regulatory Affairs Director
4 weeks 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 Pharmacist
3 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeJob OverviewCuriska is seeking a highly skilled Regulatory Affairs Pharmacist to ensure seamless product registration and dossier maintenance. The ideal candidate will have a deep understanding of regulatory guidelines and technical requirements, as well as excellent leadership and management skills.Key ResponsibilitiesProvide strategic direction and lead...
-
Regulatory Affairs Pharmacist
4 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeJob Overview:As a key member of the Curiska team, the Regulatory Affairs Pharmacist will play a crucial role in ensuring the seamless product registration process and dossier maintenance. This position requires a deep understanding of regulatory guidelines and technical requirements, as well as excellent leadership and management skills.Key...
-
Regulatory Affairs Director
4 weeks 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...
-
Regulatory Affairs Lead
4 weeks ago
Johannesburg, Gauteng, South Africa Astellas Pharma Full timeAbout Astellas PharmaAstellas Pharma is a global pharmaceutical company dedicated to delivering innovative health solutions that improve the lives of patients worldwide.We are committed to advancing patient-centricity, a guiding principle that drives our development activities and informs our decision-making at every stage.Our global vision is to support the...
-
Regulatory Affairs Pharmacist
4 weeks ago
Johannesburg, Gauteng, South Africa The Vine Partners Full timeAbout the RoleWe are seeking a skilled and detail-oriented 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 and...
-
Transformation and Business Affairs Specialist
1 month ago
Johannesburg, Gauteng, South Africa Abbott Full timeAbout the RoleThis is an exciting opportunity to join Abbott's Rapid Diagnostics division as a Transformation and Business Affairs Specialist. In this role, you will be responsible for implementing and ensuring compliance with all legislative policies related to BBBEE and Employment Equity.Key ResponsibilitiesAs a Transformation and Business Affairs...