Regulatory Specialist
About the role
This vacancy has now expired. Please see similar roles below...
Regulatory Specialist
Location: Lyon, Barcelona, Munich, London and Marlow (UK)
ICON are currently looking for a Regulatory Specialist to join our Real World Evidence team in the Lyons office preferably. Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices.
Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.
Your Responsibilities and Accountabilities:
The Regulatory Specialist works closely with the site contracts and ethics and regulatory teams in providing support in managing all regulatory aspects of the assigned projects in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPS.
Responsibilities:
In the role of Regulatory Specialist, you will be:
- Responsible for oversight of regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.
- Responsible for providing advice and support to the project team for regulatory aspects of the projects.
- Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form.
- Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
- Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Regulatory Affairs activities.
- Responsible for updating and maintaining regulatory information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing.
- Responsible for liaising with other departments on requirements for regulatory submissions.
- May act as a Contract Specialist if appropriately trained.
- Participating in the improvement of the Quality Assurance System.
You will have:
- Education to degree level
- Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP or local requirements)
- Proficiency with computer systems
- Strong verbal and written communication skills
- Strong organisational, time management, interpersonal skills.
- Ability to work both independently and in a team environment.
This is a great opportunity for someone with a good grounding in these subjects and tasks but may need to learn some element eg site contracts knowledge.
Next Steps:
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
#LI-SG2
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Shanghai
Department
Clinical Operations Roles
Location
Shanghai
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-109845
Expiry date
01/01/0001
Author
Lai "Jenny" ZhangAuthor
Lai "Jenny" ZhangSalary
Location
US, Salisbury, NC
Location
Salisbury
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Research Site Services
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117424
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
Canada, Burlington
Department
Clinical Monitoring
Location
Burlington
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Requirements: 12+ months of monitoring experience as a CRA for a sponsor or CROOncology experience as a CRA Located in Ontario, Canada At ICON, it’s our people that set us apart. Our diverse teams ena
Reference
JR117798
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
The Study Start-Up Associate (SSUA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in
Reference
2024-108919
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
US, San Antonio, TX, IDS
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
San Antonio
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Laboratory
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR113018
Expiry date
01/01/0001
Author
Alexis HenryAuthor
Alexis HenrySalary
Location
Netherlands
Department
Clinical Monitoring
Location
Netherlands
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
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
2024-109724
Expiry date
01/01/0001
Author
Vanessa VerdicktAuthor
Vanessa Verdickt