Senior Consultants UK

 

Are you an experienced specialist in Regulatory Affairs within Drug or Device Development? Become a part of the NDA Group’s growing, highly qualified team!

As a Consultant at NDA Group you provide strategic support concerning regulatory affairs of new and licensed medicines on a global, regional or national level. You will have the opportunity to manage all aspects of regulatory affairs for all types of pharmaceutical and biotech companies, from international companies to local start-ups.

Office Location: Leatherhead, UK

Qualifications

  • A minimum of 10 years of relevant experience in regulatory affairs/drug development
  • Strong commercial and client focus with ability to lead Business Development activities, with main focus on the UK market
  • Experience in leading the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies
  • Keeps abreast of EU regulatory procedures and changes
  • Direct interaction with EU regulatory agencies on defined matters
  • Extensive EU agency interactions and filing experience in the EU
  • Extensive expertise with regulatory related development procedures (e.g., scientific advice, orphan designation, paediatric development plans)
  • Global experience or knowledge about US regulations is desirable
  • Proven ability to lead cross functional teams
  • Ability to work independently
  • Strong communication skills and intercultural sensitivity

Application

Send your application (CV and cover letter) in an email labelled “NDA Consultant UK” to recruitment@ndareg.com. Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.