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Job type: Permanent

Discipline: Consultant / Specialist

Location: Switzerland

A fantastic vacancy has become available for a Senior Regulatory Consultant in Switzerland. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.

Job Responsibilities

Working on European Regulatory strategy and providing input to the International Country Roadmap, mainly for Switzerland and Rest of World support if necessary
Regulatory positioning ahead of scientific advice on the GA study endpoints
Compilation, definition and quantification of key secondary endpoints
Regulatory Slide preparation

Timelines
Procedure overviews
Status updates

Scientific Advice Briefing book preparation
Packaging strategy and analogue investigation
Support to Commercial Launch Readiness
Medical, Legal, Regulatory (MLR) compliance review of Ad-board and Patient Awareness Group materials
Early Module 1 preparation and New Active Substance positioning

Skills and Requirements

Life sciences or chemistry graduate to honours level or equivalent
Master's Degree, Post Graduate Diploma or PhD preferred
Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-PD1

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