Regulatory Operations Manager - Eastern Europe
About the role
This vacancy has now expired. Please see similar roles below...
- Responsible for oversight of compilation of regulatory submissions (NDA, MAA, IND) in eCTD format for assigned projects/countries/sites.
- Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
- Lead and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
- Maintain a strong customer service management approach with clients.
- Liaise with country-specific regulatory affairs personnel for the technical aspects of international submissions and registrations.
- Represent the company in the industry/agency electronic standards working groups.
- Lead project teams and advise other departments on regulatory standards issues and strategies
- Develop, write, and implement standards and procedures related to regulatory operations.
- Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required.
- Present services to clients/potential clients to develop new business
- Present training and seminars.
- Participate actively in other business related projects (business opportunities, client specific issues, etc.) and strategic planning.
- Client consultation and preparation of quotes and achieve utilization goals of the EU unit.
- Completing other appropriate duties as assigned by line manager that require similar skills
- 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.
- Extensive experience working with current electronic standards (e.g., eCTD, SPL, CDISC) - is required
- B.Sc. or advanced degree in Health Sciences or Information Technology
- Computer Sciences or equivalent relevant experience and training. RAC certification an asset.
- Experience in supporting business development activities an asset.
- Solid background in Regulatory Operations
- Excellent project management skills are required, as is the ability to effectively manage multiple simultaneous projects.
- The ability to interact with clients, to adapt to their priorities, and while providing strategic direction is essential.
- Ability to participate and contribute in standards development organizations
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
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Programming
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
2023-107165
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
US, Knoxville, TN
Location
Knoxville
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Nursing
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
JR118124
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
United States
Department
Scientist
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Scientist
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
2024-109511
Expiry date
01/01/0001
Salary
Location
Poland, Warsaw
Department
Full Service - Development & Commercialisation Solutions
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
Job Advert PostingAt 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’
Reference
JR119185
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
UK, Reading
Location
Dublin
Madrid
Lyon
Reading
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data Management
Data Science
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
JR117453
Expiry date
01/01/0001
Author
Angela HaugheyAuthor
Angela HaugheySalary
Location
Ireland, Dublin
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Accounting & Finance
Job Type
Permanent
Description
ICON PLC is currently recruiting for an Accounts Receivable Supervisor, to join our growing Order to Cash Team on a Permanent hybrid working basis, based in our Leopardstown HQ in Dublin.The Accounts
Reference
JR116223
Expiry date
01/01/0001
Author
Damien KehirAuthor
Damien Kehir