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)
- 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!
Send your application (CV and letter) in an email labelled “NDA Senior Consultant US West Coast” to email@example.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.