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Regulatory Operations Manager - Eastern Europe

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About the role

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Regulatory Operations Manager *LI-MB1

We change peoples lives for the better - do you want to be part of this journey?

Locations: Contracts offered in Hungary, Bulgaria, Romania, Slovenia, Slovakia, Latvia, Poland, Czech Republic, Ukraine or Turkey only.

We are currently looking for a Regulatory Operations Manager to join our Strategic Regulatory Services (SRS) team and can be based in one of the countries mentioned above. Working within SRS, 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 the project management of New Drug Applications (NDA), Marketing Authorization Applications (MAA), Investigational New Drug Applications (IND)s submissions in ECTD format, 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:
  • 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.
You will have:
  • 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
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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