Regulatory Affairs Specialist
1 day ago
Our client, an international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. The successful candidate will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.
Main Responsibilities:- Lead and manage the regulatory affairs function, ensuring seamless product registration and dossier maintenance in the SEA Cluster.
- Supervise and ensure that regulatory documentation meets relevant regulatory requirements and specifications.
- Provide input to the regulatory strategy in line with business objectives.
- Manage and implement safety updates, CMC/P&A updates and variations, and license renewals with service providers.
- Develop and maintain SOPs in line with Global SOPs, manage internal and external audits, and ensure regulatory compliance and quality-related records are available and retained.
- Coordinate product recall or market withdrawal when necessary, obtain and distribute updated information on domestic and international laws, and report ADRs to Global Safety and SAHPRA.
- Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations, identify areas for improvement within the quality system, and implement corrective and preventive actions.
- Provide training to staff on quality standards, regulatory requirements, and best practices, and maintain and manage quality-related documentation.
- Grade 12
- B. Pharm
- Registration with the South African Pharmacy Council (SAPC)
- Minimum 10 years experience in Regulatory Affairs with human medicine and biologicals experience, product registration and dossier maintenance, pharmacovigilance experience, and 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, and Microsoft Office Suite proficiency.
By submitting your CV, you confirm that:
- We may retain your personal information in our database for future matching.
- We may contact you when suitable opportunities arise.
- The information you have provided to us is true, correct, and up to date.
We endeavour to reply to each and every application, however, should you not hear back from us within 14 days, please consider your application unsuccessful.
-
Regulatory Affairs Specialist
14 hours ago
Midrand, Gauteng, South Africa The Globevest Group Full timeRegulatory Affairs Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at The Globevest Group. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and maintaining a seamless product registration process.Main Responsibilities:Lead the development and...
-
Regulatory Affairs Specialist
1 week ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.About the RoleWe are looking for a seasoned professional with expertise in regulatory affairs, particularly in human medicines, including complementary medicines and medical devices. The successful candidate will be...
-
Regulatory Affairs Specialist
1 week ago
Midrand, Gauteng, South Africa Globevest Group Full timeRegulatory Affairs ManagerCompany Overview:Globevest Group is an international pharmaceutical company with a strong presence in Midrand. We are seeking a highly skilled Regulatory Affairs Manager to join our team.Job Summary:The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulations and maintaining the company's...
-
Regulatory Affairs Specialist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key ResponsibilitiesRegulatory ComplianceManage work streams for- and report on the...
-
Regulatory Affairs Specialist
7 days ago
Midrand, Gauteng, South Africa The Globevest Group Full timeRegulatory Affairs ManagerOur client, a leading international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. As a key member of the team, you will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...
-
Regulatory Affairs Specialist
6 days ago
Midrand, Gauteng, South Africa The Globevest Group Full timeRegulatory Affairs ManagerOur client, a leading international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. As a key member of the team, you will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...
-
Regulatory Affairs Specialist
2 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key ResponsibilitiesManage work streams for- and report on the assigned portfolio of...
-
Regulatory Affairs Specialist
4 days ago
Midrand, Gauteng, South Africa The Globevest Group Full timeRegulatory Affairs Manager Job DescriptionJob Title: Regulatory Affairs ManagerCompany: The Globevest GroupLocation: MidrandJob Type: PermanentIndustry: PharmaceuticalJob Reference: RDT.S.RAMJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Midrand. The successful candidate will be responsible for ensuring compliance...
-
Regulatory Affairs Specialist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. The successful candidate will be responsible for managing work streams, reporting on assigned portfolios of products, and ensuring regulatory compliance.Key ResponsibilitiesManage work streams for- and report on the assigned portfolio of...
-
Regulatory Affairs Specialist
3 days ago
Midrand, Gauteng, South Africa The Globevest Group Full timeRegulatory Affairs Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at The Globevest Group. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and maintaining our company's pharmacovigilance standards.Main Responsibilities:Lead the development and...
-
Regulatory Affairs Director
4 days ago
Midrand, Gauteng, South Africa Jordan HR Full timeJordan HR is seeking a highly skilled and experienced professional to fill the role of Head of Regulatory Affairs Manager. The ideal candidate will possess a strong background in pharmaceutical regulatory affairs and have a proven track record of leading cross-functional teams to drive collaboration, innovation, and operational excellence. Key...
-
Regulatory Affairs Director
2 weeks ago
Midrand, Gauteng, South Africa The Globevest Group Full timeJob Title: Regulatory Affairs ManagerJob Type: PermanentIndustry: PharmaceuticalLocation: MidrandJob Description:Key Responsibilities:Lead Regulatory Affairs: Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.Product Registration: Oversee the registration process for new products, ensuring all necessary...
-
Head of Regulatory Affairs Director
4 days ago
Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full timeHead of Regulatory Affairs Job DescriptionMNA Recruitment (Pty) Ltd is seeking a highly skilled and experienced Head of Regulatory Affairs to join their team. The successful candidate will be responsible for leading the Regulatory Affairs Division and overseeing the development and delivery of a fully integrated regulatory strategy for the business.Key...
-
Regulatory Affairs Specialist: Pain, Derma
1 week ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist: Pain, DermaEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage work streams for internal...
-
Regulatory Affairs Specialist: Pain, Derma
2 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist: Pain, DermaEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage work streams for internal...
-
Regulatory Affairs Pharmacist Position
5 days ago
Midrand, Gauteng, South Africa Emporium Full timeRegulatory Affairs Pharmacist Job DescriptionEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key Responsibilities:Manage work streams for- and...
-
Regulatory Affairs Manager
1 week ago
Midrand, Gauteng, South Africa Healthcare Businesswomen's Association Full timeJob DescriptionJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support product registration and clinical trials.Key...
-
Regulatory Affairs Pharmacist Position
5 days ago
Midrand, Gauteng, South Africa Emporium Full timeRegulatory Affairs Pharmacist Job DescriptionEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key Responsibilities:Manage work streams for- and...
-
Senior Regulatory Affairs Pharmacist: OTC
14 hours ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Senior Regulatory Affairs Pharmacist: OTCEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements for our OTC medicines.Key Responsibilities:Manage work streams for- and report on the...
-
Regulatory Affairs Pharmacist
2 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeJob SummaryEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team in the Complementary Medicine department. As a Senior Regulatory Affairs Pharmacist, you will be responsible for managing work streams, reviewing regulatory agency submissions, and coordinating the submission of new product applications in South Africa and other...