Regional submission manager -Homebased in Bulgaria
- Sofia, Milan, Warsaw, Bucharest, Bratislava
- ICON Strategic Solutions
- Drug / Device Regulatory Affairs
- Remote
Talent Acquisition Team Lead
- Icon Strategic Solutions
About the role
Regional regulatory submission manager - (EU CTR) Homebased in Bulgaria
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 on our mission to shape the future of clinical development.
We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.
What you will be doing:
- Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development
- Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines
- Liaise with Sponsor Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
- Prepare, review and support Sponsor 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
- Manage the compilation for core package build, contributing to CTA and authoring documentation as required
- May be responsible for proactive processing of incoming request for information (RFIs) by daily monitoring RFI-dedicated mailbox and Clinical Trials Information System (CTIS) portal and reporting RFIs to study teams, ensuring effective communication and coordination to facilitate the smooth execution of regulatory submissions.
- May be responsible for proactive processing of payments, ensuring timely and accurate financial transactions involved in regulatory submissions.
- May manage IVD submission development and completion of relative associated documentation as required and/ or act as applicant for IVD when required
- May act as local country liaison when required
- Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities
- Discuss with relevant Sponsor SMEs the interpretation of dossier requirements
Your profile
- B.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
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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. Learn more about Our Culture at ICON
Day in the life
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 tha
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
Teaser label
Inside ICONContent type
BlogsPublish date
11/24/2022
Summary
Life sciences are undeniably an exciting area to start and pursue a career in. In fact, the global life sciences space is predicted to be worth a massive $2 trillion in gross value by 2023. Co
Similar jobs at ICON
Salary
Location
Poland, Warsaw
Location
Sofia
Milan
Warsaw
Bucharest
Bratislava
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Regulatory affairs manager to join our diverse and dynamic team. As a Regulatory affairs manager at ICON, you will play a pivotal role in contributing to drug development as
Reference
JR146109
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick HaleSalary
Location
UK, Reading
Location
Madrid
Reading
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a CMC strategy expert to join our diverse and dynamic team sitting within RA CMC. As a Senior Manager, Regulatory Affairs at ICON, you will work closely with our client to pro
Reference
JR145204
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick HaleSalary
Location
Turkey, Ankara
Location
Ankara
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development
Reference
JR143962
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick HaleSalary
Location
Korea, Seoul
Location
Seoul
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development
Reference
JR146417
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia OhSalary
Location
Poland, Warsaw
Location
Sofia
Budapest
Warsaw
Bucharest
Remote Working
Remote or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
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
JR143580
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline LockSalary
Location
Istanbul
Location
Istanbul
Remote Working
Hybrid
Business Area
ICON Strategic Solutions
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clini
Reference
JR145595
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick Hale