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Manager, Regulatory Operations - Eastern Europe

Any EU Location
Permanent
Reference: 018193
Description

Regulatory - Operations Manager

 

Locations:  Home based contracts can be offered in Hungary, Bulgaria, Romania, Slovenia, Slovakia, Latvia, Poland, Czech Republic, Ukraine or Turkey only.

 

ICON are currently looking for a Regulatory Operations Manager to join our Real World Evidence team and can be based in one of the countries mentioned above.   Working within our Strategic Regulatory Services team, you will work with a team of professionals who provide strategic and operational expertise in the area of Regulatory Affairs and Operations for Pharmaceuticals, Biologics and Medical Devices.

 

Your Responsibilities and Accountabilities:

 

The Regulatory Operations Manager  is responsible for Regulatory Operations duties to support clients in compliance with applicable regulation, the company’s Standard Operating Procedures, and project-specific operational agreements.

 

The role is responsible for submission project management, for securing new business, facilitating issue resolution, ensuring project / program timelines and budgets are met and maintaining client relationships in support of future business.

 

 

Responsibilities:

 

In the role of Regulatory Operations Manager, you will be:

 

  • Responsible for oversight of regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.
  • Responsible for providing advice and support to the project team for regulatory operations aspects  of the projects.
  • Manage 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 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 is responsible for achieving 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.

 

You will have:

 

  • B.Sc. or advanced degree in in Health Sciences or Information Technology
  • Computer Sciences or equivalent relevant experience and training. RAC certification an asset.
  • Extensive experience working with current electronic standards (e.g., eCTD, SPL, CDISC)- is  required
  • 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.
  • Ability to manage people, time and resources while developing a supportive team environment
  • 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
  • Presentation at industry conferences, publications in regulation affairs.
  •             

 

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




 





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