Senior Regulatory Consultant - AD

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. Switzerland
Zürich, Switzerland
Posting date: 29 Jan 2021
35378

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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