Regulatory Affairs Specialist
3 weeks ago
We 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 requirements.
Main Responsibilities:- Lead the development and implementation of regulatory strategies to ensure compliance with relevant regulations and industry standards.
- Manage and maintain regulatory documentation, including product registrations, dossiers, and pharmacovigilance reports.
- Provide input to the regulatory strategy in line with business objectives and ensure that all regulatory requirements are met.
- Manage and implement safety updates, product recalls, and market withdrawals as necessary.
- Develop and maintain SOPs in line with Global SOPs and ensure compliance with quality-related records.
- Manage internal and external audits, including Global and SAHPRA audits.
- Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
- Manage product complaints and deviations, and maintain regulatory documentation filing system.
- 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.
- Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
- Conduct pharmacovigilance training for local staff.
- Answer requests from the Regulatory Authority in cooperation with Global Safety.
- 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.
- Identify areas for improvement within the quality system and implement corrective measures.
- Maintain and manage quality-related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
- Ensure compliance with environmental regulations and standards at local, national, and international levels.
- 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
- Microsoft Office Suite proficiency
- Familiarity with ZAZIBONA processes and eCTD submissions
-
Regulatory Affairs Specialist
20 hours ago
Midrand, Gauteng, South Africa Emporium Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium. The successful candidate will be responsible for managing work streams, reviewing regulatory agency submissions, and ensuring compliance with regulatory standards.Key Responsibilities:Manage work streams for...
-
Regulatory Affairs Specialist
7 days ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs SpecialistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing work streams for assigned portfolios of products, including internal and external product queries, regulatory priorities, and resource...
-
Regulatory Affairs Specialist
1 week ago
Midrand, Gauteng, South Africa Emporium Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for pharmaceutical products.Key ResponsibilitiesManage work streams for- and report on the assigned portfolio...
-
Regulatory Affairs Specialist
4 weeks ago
Midrand, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs Manager Job DescriptionHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a seamless product registration process and dossier maintenance.Key Responsibilities:Lead and manage the regulatory affairs function to...
-
Regulatory Affairs Specialist
3 weeks ago
Midrand, Gauteng, South Africa Hire Resolve Full timeRegulatory Affairs Manager Job DescriptionHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring seamless product registration and dossier maintenance, while ensuring compliance with all regulations and pharmacovigilance requirements.Key...
-
Regulatory Affairs Specialist
4 weeks 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 month 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 month 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
2 weeks 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.Job SummaryWe are looking for a Regulatory Affairs Pharmacist with a strong background in pharmaceutical regulations and a proven track record of success in managing regulatory affairs for pharmaceutical products.Key...
-
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. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality and safety of our pharmaceutical products.Key Responsibilities:Manage...
-
Regulatory Affairs Specialist
1 week ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeRegulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Develop and implement regulatory strategies for pharmaceutical products, ensuring compliance with relevant laws and regulations.Collaborate with cross-functional teams to ensure regulatory requirements are met...
-
Regulatory Affairs Specialist
7 days ago
Midrand, Gauteng, South Africa Emporium Full timeRegulatory Affairs Pharmacist RoleEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for human medicines, including complementary medicines and medical devices.Key Responsibilities:Develop and...
-
Regulatory Affairs Specialist
4 weeks 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. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for pharmaceutical products.Key Responsibilities:Manage work streams for- and...
-
Regulatory Affairs Specialist
2 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeSenior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. 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 internal...
-
Regulatory Affairs Specialist
2 months 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
4 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeRegulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Develop and implement regulatory strategies for human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...
-
Regulatory Affairs Specialist
3 weeks ago
Midrand, Gauteng, South Africa Emporium Human Capital Full timeRegulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Develop and implement regulatory strategies for human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...
-
Regulatory Affairs Specialist
4 weeks 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.Key Responsibilities:Manage work streams for- and report on the assigned portfolio of products, ensuring timely and accurate submissions to regulatory agencies.Establish regulatory priorities and allocate resources and...
-
Regulatory Affairs Specialist
2 weeks ago
Midrand, Gauteng, South Africa Emporium Full timeSenior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. 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 internal...
-
Regulatory Affairs Specialist
4 weeks 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. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for pharmaceutical products.Key Responsibilities:Manage work streams for- and...