Senior Consultant, US West Coast

 

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

As Senior Consultant at NDA you provide strategic and operational 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 West Coast (home based)

Qualifications

  • 8-15 years of relevant experience in US regulatory affairs/drug development
  • Experience in 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
  • Experience of direct interaction with US regulatory agencies on defined matters including successful filing and approval of NDA/BLA
  • Experience and 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
  • Keeps abreast of US regulatory procedures and changes
  • Proven ability to lead project teams providing strategic and operational regulatory advice and guidance
  • Ability to contribute to Business Development activities, with main focus on the US West Coast
  • Ability to work independently is very important
  • Strong communication skills and intercultural sensitivity

To succeed as Senior Consultant you are probably proactive, adaptable and confident in decision-making.

Is this you? Welcome with your application!

Application

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

To read more about NDA Group click here.