Senior Regulatory Affairs Consultant - CMC (UK)

Parexel International Corporation

United Kingdom - Any Region - Home Based

Job Purpose:

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 PC 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 PC and the client.

* anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.QualificationsKnowledge and Experience:

• Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

• Experience of supporting / coordinating Marketing Authorisation Transfers (MAT's) would be desirable

• Project Management Experience, Project management qualification would be a plus


* Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred


* High-level consulting skills

* Critical thinking and problem-solving skills

* Project leadership and management knowledge

* Excellent interpersonal and intercultural communication skills, both written and verbal

* Client-focused approach to work

* Results orientation

* Teamwork and collaboration skills

* Proficiency in local language and extensive working knowledge of the English language

* Networking

* Business analysis

* Self-confidence and control

2021-07-25 00:05:17

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