Regulatory Operations Manager - Eastern Europe
About the role
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- 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
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