Principal Consultant

 

Are you an experienced specialist in regulatory affairs within drug development? Become a part of NDA’s growing, highly qualified team!

As Principal Consultant at NDA you provide strategic support concerning regulatory affairs within drug development on a global, regional or national level. You manage large, complex and/or unpaved projects from international companies or local start-ups.

Location: US East Coast (home based), preferable Boston area

Qualifications

  • A minimum of 15 years of relevant experience in US regulatory affairs/drug development
  • Strong commercial and client focus with ability to lead Business Development activities, with main focus on the US East Coast
  • 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 US regulatory procedures and changes
  • Direct interaction with US regulatory agencies on defined matters
  • Extensive US agency interactions and filing experience in the US
  • Extensive expertise with regulatory related development procedures (e.g., scientific advice, orphan designation, paediatric development plans, fast track)
  • Global experience or knowledge about EU regulations is a merit
  • Proven ability to lead cross functional teams
  • Ability to work independently is very important
  • Strong communication skills and intercultural sensitivity

Is this you? Welcome with your application!

Application

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