Regulatory Operations Associate
About the role
This vacancy has now expired. Please see similar roles below...
Regulatory Operations Assistant *LI-MB1
Locations: Only Eastern European countries can be considered
We are currently looking for an experienced Regulatory Operations Assistant (document and submission publisher) to join our Strategic Regulatory Services (SRS) - you will be working within SRS, within a team of professionals who provide strategic and operational expertise in the area of Regulatory Affairs and Operations for Pharmaceuticals, Biologics and Medical Devices. In return, we will offer you a supportive and engaging working environment.
We would like for you to support clients in compliance with applicable regulation, the company’s Standard Operating Procedures, and project-specific operational agreements
Responsibilities:
- The primarily responsibilities of this job include:
- Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
- Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
- Maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
- Assemble electronic and paper Regulatory Submissions and packages for US Food and Drug Administration, the European Medicines Agency, Health Canada, and other international regulatory authorities
- Perform quality review of Regulatory Operations team members work to ensure accuracy.
- Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.
- Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and clients.
- Assist in the design and implementation of new processes or initiatives within the department.
You will have:
- Experience working with current electronic regulatory standards (e.g., eCTD, SPL, IDMP) is an asset
- Fluent English
- B.Sc. degree in Health Sciences or Information Technology
- Proven knowledge of a variety of computer programs including MS Office, Adobe Acrobat
- Ability to effectively handle multiple simultaneous projects.
- The ability to get along with clients, to adapt to their priorities, and while providing strategic direction is important.
- Ability to maintain a high level of accuracy and attention to detail.
- Ability to work collaboratively as part of a team.
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
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2024-109942
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2024-109699
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2024-109696
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2024-109698
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2024-109554
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2024-109464
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins