Senior Regulatory Affairs Manager

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
London, England
Posting date: 29 Jan 2021
35379

A popular hospital in search of an experienced Regulatory Affairs Manager to ensure regulatory excellence in Switzerland.

Job Responsibilities

  • Project management of LOQ responses
  • Timelines management
  • Key Subject Matter Expert (SME) follow-up and tracking
  • Guideline research
  • Management of Readability testing
  • Regulatory Slide preparation
  • Timelines
  • Procedure overviews
  • Status updates

Skills and Experience:

  • Graduate in a life science subject as a minimum, post graduate degree desirable
  • Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred
  • Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications
  • Keeps up to date with professional knowledge, expertise and best practice.
  • Excellent oral and written communication skills.

To Apply

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

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