A Principal Consultant (Biologics CMC Expert) must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills and must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services Parexel Consulting provides.
Key Overall Responsibility is to:-
* provide a full range of consulting services and works within their personal area of expertise. * provide mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.
We are currently seeking an EU CMC SME, aligned with the following profile:
• Senior regulatory/ CMC professional with specialized expertise in the CMC development of biological medicinal products for the European market. Experience in CMC development, drafting of dossier sections, IMPD’s, health authority meetings etc. for the EU market
Education • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree (i.e. MBA) preferred.
Language Skills • At least fluent vocal and written English.
Minimum Work Experience • Numerous years’ experience with expert level industry or regulatory knowledge. Prior experience working for a National Health Authority is a strong advantage.