CTA submission Manager
- UK
- ICON Strategic Solutions
- Regulatory Affairs
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
CTA Submission Manager - Homebased in UK/ Europe
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, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life
The CTA Submission Manager is accountable for submissions execution for designated CTAs.
You will operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
ROLE RESPONSIBILITIES:
- Drives global submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes
- Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
- CTA Manager may act as local country liaison when required
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
Qualifications -
- S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of CTA and Central Ethics processes globally
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standard
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
IndustryContent type
BlogsPublish date
01/18/2024
Summary
Introduction to Regulatory Affairs in Clinical Research Regulatory affairs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. In the
Who we are
Similar jobs at ICON
Salary
Location
United Kingdom
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Regulatory Affairs Manager- (EU CTR) Homebased in UK/Ireland Only Due to recent success within one our Innovative Biotech Clients I am recruiting for a Regulatory Affairs manager at ICON - Working in
Reference
2024-110077
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick HaleSalary
Location
Ireland, Dublin
Department
Full Service - Development & Commercialisation Solutions
Location
Farmingdale
Dublin
Reading
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
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
JR116607
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline LockSalary
Location
Mexico City
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Mexico City
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in
Reference
2024-109793
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Korea, South
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
South Korea
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
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
2024-109948
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia OhSalary
Location
India, Chennai
Department
Clinical Trial Management
Location
Bangalore
Chennai
Bengaluru
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
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
JR117226
Expiry date
01/01/0001
Author
Amrutha SaidalaAuthor
Amrutha Saidala