Regulatory Affairs Portfolio Lead
7 days ago
Manage work streams for- and report on the assigned portfolio of products: Assisting with internal product queries from relevant departments Assisting with external product queries from the SAHPRA, other MRAs and third-party stakeholders Establish regulatory priorities and allocate resources and workloads Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards Artwork reviews and approvals Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to Develop regulatory strategies and implementation plans for the preparation and submission of new products Conduct dossier due diligence to ensure all data gaps are addressed Prepare the registration applications for submission to the regulatory authorities Work in collaboration with internal and external stakeholders to assess regulators submissions requirements Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. Internal training and mentoring Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced, including reporting and metrics management. Support activities such as internal audits or regulatory agency inspections Ensure alignment of personal and company value Bachelors degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council 3 to 5 years experience in Regulatory Affairs, preferably in human medicines Demonstrable experience across the product development, commercialization and maintenance lifecycle Sound project management capabilities Proven ability to consistently deliver to quality, time and cost standards Experience in use of CTD software builder and compilation of eCTD applications. IT skills Ability to prioritise and work to tight deadlines Systems and operations analysis Basic cost management skills Active learning Strategic thinking Ability to cope with a high degree of complexity and change Cross Functional skills: Ability to network, liaise and negotiate with others Ability to set standards and objectives and monitor progress Complex problem solving and decision-making skills Customer relationships Development of people Must demonstrate responsibility, excellence and collaboration and align with Company values
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Regulatory Affairs Portfolio Lead
2 days ago
Johannesburg South, South Africa Emporium Human Capital Full timeRegulatory Affairs Portfolio Lead (POS25036)MIDRANDSalary: R1MReporting to: Regulatory Affairs ManagerJob Overview:Support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs. To ensure legal and...
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Regulatory Affairs Pharmacist
4 days ago
Johannesburg, South Africa Stafflink Recruitment Solutions Full time**Minimum Requirements**: Bachelors degree in Pharmacy, registered with the South African Pharmacy Council MSc, MBA or PhD may be an advantage Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience. Experience in registration of products and regulatory knowledge on South Africa, Botswana, Namibia, Mauritius,...
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Regulatory Affairs Director
3 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs ManagerAt Emporium Human Capital, we are seeking a highly skilled Regulatory Affairs Manager to lead our regulatory team and provide superior services to relevant departments within the company.Key Responsibilities:Lead the regulatory team to ensure legal compliance with medicine regulatory authorities, laws, and...
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Regulatory Affairs Pharmacist
2 weeks ago
Johannesburg, South Africa Ad Talent Africa Full time**Who are we**: An innovative leading pharmaceutical company. **Who are we looking for**: A Regulatory Affairs Pharmacist. **What will you do**: - Compilation and submission of post-registration amendments to ensure dossier compliance - Responsible for pre - and post - registration SAHPRA committee recommendation responses to ensure product registration -...
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Regulatory Affairs Manager
7 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...
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Regulatory Affairs Specialist
3 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeJob Title: Regulatory Affairs SpecialistAbout the Role:The Emporium Human Capital is seeking a skilled Regulatory Affairs Specialist to join our team. This role will be responsible for providing superior Regulatory services to relevant departments within the company and with external partners and principals.Key Responsibilities:Support the Regulatory team to...
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Senior Regulatory Affairs Manager
3 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeAbout UsEmporium Human Capital is a leading recruitment agency specializing in the healthcare sector. We are committed to finding the best talent for our clients and helping them achieve their goals.Job DescriptionThe Regulatory Affairs Pharmacist will be responsible for managing work streams, establishing regulatory priorities, and allocating resources. The...
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Regulatory Affairs Specialist
3 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeEmporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in regulatory affairs and a passion for ensuring compliance with relevant laws and regulations.This role is responsible for leading the regulatory team to provide superior services to internal departments and...
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Snr Regulatory Affairs Portfolio Manager
7 months ago
Johannesburg, South Africa Abbott Laboratories Full time**About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full...
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Regulatory Affairs Pharmacist
7 months ago
Johannesburg South, South Africa Emporium Human Capital Full timeRegulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...
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Senior Regulatory Affairs Pharmacist
7 months ago
Johannesburg, South Africa PSM Personnel Full timeSenior Regulatory Affairs Pharmacist Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications/experience - Bachelors Degree or Diploma in Pharmacy with the South African Pharmacy Council registration. - +-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end...
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Regulatory Affairs Manager
7 months ago
Johannesburg South, South Africa Emporium Human Capital Full timeRegulatory Affairs Manager (POS24191)Area: AerotonR1,5 1,7k paLead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country...
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Regulatory Affairs Manager
1 week ago
Johannesburg, South Africa Boehringer Ingelheim Full timeRegulatory Affairs Manager-228704 **Regulatory Affairs Manager - Human Pharma Business (ID: 228704)** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000...
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Regulatory Affairs Strategic Manager
6 days ago
Johannesburg, Gauteng, South Africa Unique Personnel Ltd Full timeJob Description:At Unique Personnel Ltd, we are seeking a highly skilled Regulatory Affairs Portfolio Lead to join our team. This role is responsible for managing work streams and reporting on assigned portfolios of products.Main Responsibilities:Assisting with internal product queries from relevant departmentsAssisting with external product queries from the...
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Senior Regulatory Affairs Pharmacists
7 months ago
Johannesburg, South Africa Unique Personnel Full time**Job Number** - 72990 **Job Type** - Permanent **Job Title** - Senior Regulatory Affairs Pharmacists **Computer Skills** - Mcrosoft Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting to Regulatory Affairs Manager** **Job purpose**: - Support the Regulatory team to provide superior...
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Regulatory affairs Manager
4 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....
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Regulatory affairs Manager
4 months ago
Johannesburg, South Africa Curiska 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...
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Regulatory Affairs Pharmacist Professional
3 weeks ago
Johannesburg South, South Africa Emporium Human Capital Full timeJob OverviewEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. The successful candidate will be responsible for managing work streams, establishing regulatory priorities, and allocating resources.The ideal candidate will have a strong background in Regulatory Affairs, with experience in human medicines,...
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Regulatory Affairs Pharmacist
7 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...
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Senior Regulatory Affairs Pharmacist
18 hours ago
Johannesburg, South Africa Abbott Laboratories Full time**Division**: Abbott Established Pharmaceuticals Division** **Reports to**:Head of Regulatory Affairs** **Location**:Johannesburg*** **Primary Objective of Position**: - Ensure new medicinal products are registered and existing registrations are maintained in accordance with current regulations of each country within the English Africa Cluster (EAC). -...