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 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 preferably Princeton, NJ, Philadelphia, PA or Boston, MA area.
- A minimum of 10 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
- Strong communication skills and intercultural sensitivity
Send your application (CV and cover letter) in an email labelled “NDA Group Consultant US East Coast” to firstname.lastname@example.org. Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.