CTA submission manager
- Any EMEA Location
- ICON Strategic Solutions
- Regulatory Affairs
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.jpg)
Teaser label
Inside ICONContent type
BlogsPublish date
01/17/2025
Summary
Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are
.png)
Teaser label
Our PeopleContent type
BlogsPublish date
11/13/2024
Summary
How to Become a Clinical Research Associate: A Step-by-Step Guide The clinical research industry is projected to reach $52.0 billion by 2026, growing at an impressive rate of 5.6% annually. This
.jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Similar jobs at ICON
Salary
Location
Georgia, Tbilisi
Location
Tbilisi
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Job Responsibilities: • Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance • As a member of staff, the employee is expected to embra
Reference
JR131117
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
Poland, Warsaw
Department
Full Service - Regulatory
Location
Sofia
Warsaw
Johannesburg
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Job Responsibilities:• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with soun
Reference
JR129985
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
South Africa, Johannesburg
Department
Full Service - Regulatory
Location
Sofia
Warsaw
Johannesburg
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Senior Global Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Global Regulatory Affairs Specialist at ICON, you will play a pivotal role in d
Reference
JR129102
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline LockSalary
Location
India, Chennai
Department
Clinical Trial Management
Location
Bangalore
Chennai
Bengaluru
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
JR126981
Expiry date
01/01/0001
Author
Amrutha SaidalaAuthor
Amrutha SaidalaSalary
Location
UK, Reading
Location
Sofia
Warsaw
Reading
Gdansk
Warwickshire
Swansea
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Regulatory Project Manager (RPM) to join our diverse and dynamic Regulatory Project Services (RPS) team. As an RPM at ICON, you will play a pivotal role in contributing to d
Reference
JR130377
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
Japan, Tokyo
Location
Osaka
Tokyo
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analy
Reference
JR127715
Expiry date
01/01/0001
Author
Haruna YamabayashiAuthor
Haruna Yamabayashi