Senior Regulatory Affairs Consultant - CMC (UK)
Parexel International Corporation
United Kingdom - Any Region - Home Based
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
* Business analysis
* Self-confidence and control