Senior Regulatory Consultant - AD
- Permanent
- Consultant / Specialist
- 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.
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