Regulatory Affairs Expert
2 weeks ago
At Icon Plc, we are seeking a highly skilled Regulatory Affairs Expert to join our dynamic team. As a key member of our organization, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Responsibilities:- Coordinate all Central Independent Ethics Committee (IEC), Regulatory Agency (RA), and other central authority submissions to ensure adherence to contractual timelines.
- Communicate submission status updates to the Start-Up Lead (SUL) and collaborate to mitigate risks to Sponsor deliverables.
- Provide the Sponsor and internal Project Team with information on regulations governing the clinical trial at a project level.
- Address Sponsor queries related to regulatory and submission requirements.
- Prepare the Core Clinical Trial Application and perform quality control (QC) on the content of all central submission packages.
- Support Business Development efforts by contributing regulatory input for Requests for Proposal (RFPs), Requests for Information (RFIs), and participation in Bid Defense Meetings.
- Bachelor's degree in a scientific discipline or related field.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements and guidelines.
- Excellent communication in English.
- Ability to work independently and collaboratively in a fast-paced environment.
- Varying annual leave entitlements.
- A range of health insurance offerings to suit your needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the future.
- Global Employee Assistance Programme, offering 24-hour access to a network of professionals for support.
- Life assurance.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, and health assessments.
-
Regulatory Affairs Expert
2 weeks ago
Pretoria, Gauteng, South Africa Bridge Personnel Concepts Full timeQuality and Regulatory Affairs Role OverviewWe are seeking a talented Regulatory Affairs Expert to join our team in Solventum Johannesburg. As a key member of our Quality and Regulatory Affairs department, you will play a crucial part in ensuring compliance with established quality principles and promoting continuous improvements to productivity, quality,...
-
Regulatory Affairs Specialist
2 days ago
Pretoria, Gauteng, South Africa Allergan Aesthetics Full timeAbout the RoleAs a Senior Regulatory Affairs Specialist at Allergan Aesthetics, you will play a critical role in ensuring that our innovative medicines and solutions meet the regulatory requirements of various health authorities in Africa. Your expertise will be essential in maintaining our product registrations and ensuring compliance with local, regional,...
-
Regulatory Affairs Professional
2 weeks ago
Pretoria, Gauteng, South Africa Findojobs-Za Full timeWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Findojobs-Za. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with domestic and international regulations, developing and implementing quality control procedures, and providing expert medical reviews.Key...
-
Regulatory Affairs Expert
6 days ago
Pretoria, Gauteng, South Africa Afrizan People Intelligence Full timeAfrizan People Intelligence is seeking a seasoned Regulatory Affairs Expert to drive Alternative Dispute Resolution processes and provide high-level legal advisory services.Key Responsibilities:Represent the organisation in ADR processes ensuring disputes are resolved within set timelines.Drafting legal agreements and presenting them to internal governance...
-
Regulatory Affairs Expert
1 week ago
Pretoria, Gauteng, South Africa Allergan Full timeJob Overview:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Allergan. The successful candidate will be responsible for ensuring that new products are registered and existing registrations are maintained in accordance with the current requirements of the various Health Authorities in Africa.About the Role:This is an...
-
Regulatory Affairs Director
2 weeks ago
Pretoria, Gauteng, South Africa MNA Recruitment Full timeJob OverviewThe position of Regulatory Affairs Manager is a critical role within our organization, responsible for ensuring compliance with relevant medicine regulatory authorities. The ideal candidate will have a strong background in pharmacy and experience in regulatory affairs.
-
Regulatory Affairs Manager
2 weeks ago
Pretoria, Gauteng, South Africa Dimension Data Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Dimension Data. In this role, you will be responsible for managing regulatory affairs and ensuring that our company complies with all relevant laws and regulations.You will also assist with reviewing contracts and performing legal research on various topics.The ideal...
-
Regulatory Affairs Specialist
2 weeks ago
Pretoria, Gauteng, South Africa Emporium Human Capital Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium Human Capital.The ideal candidate will have a strong background in regulatory affairs, with experience in managing work streams and reporting on assigned portfolios of products. You will be responsible for establishing regulatory priorities, allocating...
-
Regulatory Affairs Specialist
6 days ago
Pretoria, Gauteng, South Africa MNA Recruitment Full timeA highly skilled Regulatory Affairs professional is required to lead our team and ensure compliance with regulatory requirements. The successful candidate will have a strong background in pharmaceutical regulations, excellent communication skills, and the ability to work effectively in a fast-paced environment.Job Overview:The Regulatory Affairs Manager will...
-
Regulatory Affairs Manager
2 weeks ago
Pretoria, Gauteng, South Africa Findojobs South Africa Full timeAbout the RoleThe Regulatory Affairs Manager will play a critical role in ensuring compliance with regulatory requirements and developing policies to mitigate risk.Key ResponsibilitiesDeveloping and implementing regulatory compliance programsRequired Skills and QualificationsBachelor's degree in Business Administration or related fieldMinimum 3 years of...
-
Regulatory Affairs Director
6 days ago
Pretoria, Gauteng, South Africa Emporium Human Capital Full timeAs a key member of the Emporium Human Capital team, you will lead the Regulatory Affairs function to deliver exceptional regulatory services to internal stakeholders and external partners. This role requires a strong understanding of regulatory compliance and a proven track record in managing complex regulatory portfolios.The ideal candidate will possess a...
-
Regulatory Affairs Lead
23 hours ago
Pretoria, Gauteng, South Africa MNA Recruitment Full timeJob OverviewMNA Recruitment is seeking a highly skilled Regulatory Affairs Manager to lead our team in providing superior Regulatory services.About the RoleThis exciting opportunity requires a candidate with minimum 5 years' experience in Regulatory Affairs, preferably in human medicines.Manage work streams for assigned portfolios and report on...
-
Regulatory Affairs Specialist
11 hours ago
Pretoria, Gauteng, South Africa Pele Energy Group Full timeWe are looking for a Regulatory Affairs Specialist to join our team at Pele Energy Group. As a key member of the team, you will play a crucial role in ensuring that the Company complies with all relevant regulatory and business practices.Key ResponsibilitiesConduct and coordinate periodic assessments from a Compliance perspective for the Company on different...
-
Regulatory Affairs Specialist
1 week ago
Pretoria, Gauteng, South Africa MNA Recruitment Full timeA leading pharmaceutical company is seeking an experienced Regulatory Affairs SpecialistJob Reference: MNA003453-SS-4About the RoleThis is a key position within our organisation, reporting directly to the Head of Regulatory Affairs. The successful candidate will be responsible for providing strategic regulatory advice and guidance to ensure compliance with...
-
Regulatory Affairs Manager
5 days ago
Pretoria, Gauteng, South Africa MNA Recruitment Full timeJob DescriptionA highly motivated and experienced Senior Regulatory Affairs Manager is required to join our team at MNA Recruitment. The successful candidate will be responsible for coordinating, project controlling, and providing regulatory support to ensure continuous compliance and product supply.Key Responsibilities:Completion of all assigned training...
-
Regulatory Compliance Expert
2 days ago
Pretoria, Gauteng, South Africa Allergan Aesthetics Full timeResponsibilitiesThe Senior Regulatory Affairs Specialist will be responsible for the following:Advancing Pipeline/Market Product Support: Ensure timely preparation, filing, and approval of regulatory submissions (new applications and variations) to meet business targets covering the respective products in Country.Maintaining Existing Product Marketing...
-
Regulatory Affairs Professional
4 days ago
Pretoria, Gauteng, South Africa Department of Water and Sanitation Full timeAbout the RoleThe Department of Water and Sanitation is seeking a highly skilled Regulatory Affairs Professional to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring that our regulations and policies are effective in protecting our water resources.Your primary responsibility will be to develop and...
-
Regulatory Affairs Specialist
1 week ago
Pretoria, Gauteng, South Africa Mayfly Agri (Pty) Ltd Full time**Job Overview**Mayfly Agri (Pty) Ltd is a leading agribusiness seeking an experienced Regulatory Affairs Specialist to join its team.The ideal candidate will have a strong background in regulatory affairs, with expertise in developing and maintaining standard operating procedures, training staff on regulatory policies, and managing audits and...
-
Regulatory Affairs Director
4 days ago
Pretoria, Gauteng, South Africa MNA Recruitment Full timeJob OverviewWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulations and guidelines in Central East Africa and Mauritius Regions.ResponsibilitiesCoordinate submissions/ variations according to strategic plan and...
-
Regulatory Affairs Specialist
6 days ago
Pretoria, Gauteng, South Africa Massmart Holdings Limited Full timeRole OverviewThis position requires a deep understanding of antitrust law and regulatory affairs to drive business growth and mitigate risk. As a Subject Matter Expert, you will be responsible for designing and directing the implementation of strategic risk mitigation programs.Key Responsibilities:Implement and direct the implementation of competition...