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Senior Regulatory Affairs Consultant (MA Transfer)

Parexel International Corporation

Romania - Any Region - Home Based

We are seeking to find a Senior Regulatory Affairs Consultant with strong project leadership skills, who can lead large MAT projects.

The role can be office or home based in Romania.

A Senior Consultant: must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services Parexel Consulting provides. develops specialist knowledge of a particular subject matter or market. provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. serves either as an individual contributor, a workstream lead or provides overall project leadership. provides guidance to project team members on technical/process issues. ensures the timely performance of work within a project scope to the quality expectations of Parexel Consulting and the client. anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers. QualificationsIdeal candidate will possess: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus Experience with Marketing Authorization Transfers (MAT's) Project Management Experience, Project management qualification would be a plus High-level consulting skills Excellent interpersonal and intercultural communication skills, both written and verbal Client-focused approach to work Proficiency in local language and extensive working knowledge of the English language

Job posted: 2021-07-03

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