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Regulatory Affairs Specialist

India-Chennai
Permanent
Reference: 054618
Description

·         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.

·         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

·         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


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