JUMP TO CONTENT

Strategic Solutions - Regulatory Affairs/ Drug Safety/ Quality Assurance

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 Submissions Support

Strategy

employees talking

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

employees talking

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

employees talking

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.

ICON has developed strategic partnerships with many of the world’s largest pharma companies - and every partnership evolves with our client's needs and Regulatory compliance. This is evidenced by our capabilities that have led to the approval of 18 of the world’s top 20 best-selling drugs. Regulatory Affairs is a growing group across the industry and we are proud to highlight many career opportunities globally.

employees clapping

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.

employees pointing at a laptop screen


Hear from our Regulatory and Medical Writing team on their career growth at ICON Strategic Solutions.

Press play to find out more

List #1

Roles in this area

Financial Management Lead/Tasker Support

Salary

Location

United States, Remote

Department

Government Public Health Services (IGP)

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2023-99523

Expiry date

03/28/2023

Read more Shortlist Save this role
Drug Safety Associate

Salary

Location

United Kingdom

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

UK

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2023-101495

Expiry date

05/19/2023

Read more Shortlist Save this role
Senior Clinical Supplies Project Manager

Salary

Location

Remote

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Logistics & Supplies

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2023-100181

Expiry date

04/17/2023

Brandon Pupek

Author

Brandon Pupek
Read more Shortlist Save this role
Talent Acquisition Coordinator (Mexico City-3 Days Office/2 Days Home per Week)

Salary

Location

Mexico

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Mexico

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Temporary Employee

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2023-102501

Expiry date

05/23/2028

Rita Villavicencio Read more Shortlist Save this role
Clinical Account Sales Executive (ICON Government Division)

Salary

Location

Remote

Department

Government Public Health Services (IGP)

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Business Development

Job Type

Permanent

Description

As a Account Executive you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Account Executive is a key role within the G

Reference

2023-102551

Expiry date

05/22/2028

Read more Shortlist Save this role
Research Technician

Salary

Location

United States

Department

Government Public Health Services (IGP)

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Laboratory

Job Type

Permanent

Description

As a Research Technician IV you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will join a dynamic and growing team at

Reference

2023-102403

Expiry date

05/16/2028

Read more Shortlist Save this role
View all

Browse popular job categories below or search all jobs above