Regulatory Affairs
At ICON Strategic Solutions, we are experts at helping our clients to navigate through the complexities of global regulatory requirements and emerging issues by supporting with resourcing provisions and ramp-ups of embedded Regulatory professionals.
Strategy
Having the right strategy is crucial at all stages of the product lifecycle. Whether you’re preparing for your first pre-IND/CTA meeting or approaching patent expiration, we will help you consider all the options so you can take the most strategic stance.
Submissions
Doing a submission right the first time can make the difference between being first to market or just another me-too. Whether it is an eCTD to the FDA, an orphan drug application in Europe, or a medical device, our experts will help you get to market quickly and smoothly.
Support
We provide temporary on-site support for organizations that find themselves suddenly overloaded. Our extra hands and minds can make things happen fast—and by providing you with regulatory assistance on routine work, our support can help you focus on your top priorities.
Pharmacovigilance & Drug Safety
ICON Strategic Solutions Pharmacovigilance team members bring together all safety services into a seamless and transparent delivery solution, with easy-to-review outputs, a strong focus on continuous quality improvement, and operational efficiency ensuring patient safety. Our client-embedded employees process cases based on an innovative cloud-based system, featuring automated and configurable business rules. This enables them to gain visibility into the safety profile of an investigational product throughout its lifecycle.
We provide a comprehensive range of drug safety services, minimising risk and protecting patient well-being from clinical development to post-marketing.
By using versatile technologies, targeted data collection, and reports from multiple sources, our experts support our clients in protecting patients. These services help to detect, assess, understand, quantify, and minimsze the risk of adverse reactions.
Pharmacovigilance is a growing area in the industry and we have many career opportunities available.
Quality Assurance
ICON Strategic Solutions has the resources to meet your requirements for Phase I - IV clinical trials.
In addition to providing in-house Quality Assurance auditing for all clinical trials, the Quality Assurance department provides stand-alone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GMP and GLP regulations.
Our QA services encompass the following:
- Auditing
- Phase I facilities
- Phase I - IV GCP audits
- Clinical laboratories (GCP, GLP)
- Database and Statistical tables
- Computer validation
- Clinical trial reports
- Pre-FDA/regulatory inspections
- Quality Systems Development (GCP, GLP)
With QA personnel located across Europe, the US, Asia-Pacific, Latin America and Japan, the ICON QA team is flexible enough to provide individual and personalised career development paths and services for locally managed projects.
Hear from our Regulatory and Medical Writing team on their career growth at ICON Strategic Solutions.
Salary
Location
South Africa
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
South Africa
Remote Working
Remote
Job Categories
Quality Assurance
Job Type
Permanent
Description
Title – Clinical Quality and Training Manager Sub-Saharan Africa region (South Africa Based)Location – South Africa Sponsor dedicated ICON plc is a world-leading healthcare intelligence and clinical r
Reference
2024-110032
Expiry date
01/01/0001
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Salary
Location
Japan
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Japan
Job Categories
Drug Safety
Job Type
Permanent
Description
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現 ・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ
Reference
2024-109906
Expiry date
01/01/0001
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Salary
Location
Europe
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Any EMEA Location
Remote Working
Remote
Job Categories
Other
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109940
Expiry date
01/01/0001
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Salary
Location
United Kingdom
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
UK
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
CTA Submission Manager - Homebased in UK/ EuropeICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providin
Reference
2024-109875
Expiry date
01/01/0001
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Shortlist Save this role
Salary
Location
Japan
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Japan
Job Categories
Drug Safety
Job Type
Permanent
Description
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現 ・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ
Reference
2024-109907
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Japan
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Japan
Job Categories
Drug Safety
Job Type
Permanent
Description
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現 ・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ
Reference
2024-109903
Expiry date
01/01/0001
Read more
Shortlist Save this role