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
West Point
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
West Point
Remote Working
Office Based
Job Categories
Logistics & Supplies
Job Type
Permanent
Description
As a Label Project Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This role will require 2/3 day onsite i
Reference
2025-119364
Expiry date
01/01/0001
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Salary
Location
Romania, Bulgaria, Hungary
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Bulgaria
Hungary
Romania
Job Categories
Laboratory
Job Type
Permanent
Description
As a Laboratory Study Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The Laboratory Study Associate (LSA) wit
Reference
2025-119441
Expiry date
01/01/0001
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Salary
Location
Sofia
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Sofia
Remote Working
Remote
Job Categories
Corporate Support
Job Type
Permanent
Description
As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119143
Expiry date
01/01/0001
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Salary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Job Categories
Other
Job Type
Permanent
Description
As a Director, Imaging Operations you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119363
Expiry date
01/01/0001
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Salary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Job Categories
Other
Job Type
Permanent
Description
As a Senior Medical Director, Biotech you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119362
Expiry date
01/01/0001
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