Regulatory affairs Manager
2 months ago
Hiring: Regulatory Affairs Manager
Location: Midrand, South Africa
As a Regulatory Affairs Manager, you will 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: 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.
Requirements
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, South Africa Jobted ZA C2 Full timeHiring: Regulatory Affairs Manager Location: Midrand, South Africa As a Regulatory Affairs Manager, you will 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...
-
Regulatory Affairs Manager
5 months ago
Johannesburg, South Africa PSM Personnel Full timeRegulatory Affairs Manager Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications and Experience - Bachelors degree in Pharmacy/Diploma in Pharmacy - Registration with the South African Pharmacy Council - Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines - Demonstrable experience across the product development,...
-
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:Develop and implement regulatory strategies and documentation.Ensure compliance with regulatory...
-
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:Develop and implement regulatory strategies and documentation.Ensure compliance with...
-
Regulatory Affairs Manager
5 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 72786 **Job Type** - Permanent **Job Title** - Regulatory Affairs Manager **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting to Head: Regulatory Affairs** **Job purpose**: - Support the Regulatory team to provide superior Regulatory services...
-
Regulatory affairs Manager
2 months ago
Johannesburg, South Africa Curiska Full timeHiring: Regulatory Affairs Manager Location: Midrand, South Africa As a Regulatory Affairs Manager, you will 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....
-
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 Manager
2 months 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
2 months ago
Johannesburg, South Africa Curiska (Pty) Ltd Full timeHiring: Regulatory Affairs ManagerLocation: Midrand, South Africa As 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...
-
Regulatory Affairs Pharmacist
5 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 71064 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Adobe Acrobat,MS Excel **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems, ensuring...
-
Regulatory Affairs Pharmacist
5 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 72989 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - To Support the Regulatory Affairs team with...
-
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
1 week 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...
-
Head of Regulatory Affairs
5 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 71851 **Job Type** - Permanent **Job Title** - Head of Regulatory Affairs **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting To Managing Director - company OTC** **Job Purpose** - The Head of Regulatory Affairs holds ultimate responsibility...
-
Regulatory Affairs Specialist
3 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs SpecialistJob Summary:Emporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for providing superior Regulatory services to relevant departments within the company and with external partners and Principals.Key...
-
Head of Regulatory Affairs
5 months ago
Johannesburg, South Africa PSM Personnel Full timeHead of Regulatory Affairs Pharmacist ~ Regulatory Johannesburg North-Gauteng We are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you...
-
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...