ONCOLOGY ** (Sr) Regulatory Director ** Have solid full project lifecy (Somerset)
Advanced S&S (USA)
: $177,070.00 - $177,070.00 /year *
: Healthcare - Physician
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ONCOLOGY ** Director / Sr Director US Lead ** Solid product level ** Have full lifecycle and now want to work in a pure development regulatory role? US East Coast / Tri-State with Relo ______________________________________________________________________
You will be someone who likes to be working at the project and product level, leading US interactions, managing the preparation of complex first line NDAs, and showing the ropes to less experienced US Regulatory Professionals, for sNDAs and combination drug studies and submissions.
You might be working in a smaller company covering the full regulatory lifecycle or have had your focus change to be more on lifecycle and are missing the cut and thrust of supporting regulatory submissions for clinical studies and resulting NDAs/BLAs, either way it will be great to hear from you. The company is offering 3 distinct advantages:-
Role is based East Coast , TriState area, with a relocation which will help you move up or relocate, including house sale / purchase and temporary support Diverse, expansive pipeline, this group are managing >60 IND programmes as an example of this , and are funding in Oncology a. 20% of R&D to T/O Highend package, strong basic and bonus elements, for the right person they will buy out any existing stock plan!
In return, my client is seeking individuals with Oncology regulatory expertise, although you might have more recently worked in other therapy areas, who have:-
Co- or led NDA or NDA/BLA submissions, or a round of sNDAs including US FDA pre-submission and review meetings; solid track record in health authority negotiations A good way of being about you: know how to push an idea to develop smart strategies, know how to calibrate with the other regions during major hurdles, and like working in a collegiate way where people share and respond to each other Live around or are willing to relocate to the TriState area; the company can offer 3 days in the office, 2 days from home Want to consolidate and further develop your Oncology experience and are willing to share knowhow and coach / mentor regulatory professionals supporting your programmes.
Please note: if you feel you would like to grow into more of a GRL type role, we also have a potential vacancy for you and would welcome your application.
To apply, please contact one of our two Senior Recruiters , either myself or my colleague Matt Greig or Theo Moore on US Toll Free > _______________________________________________________________________
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.