ONCOLOGY ** (Sr) Regulatory Director ** Have solid full project lifecycle and...?

Location
Tri-State
Salary
On Application
Posted
25 Mar 2019
Closes
24 Apr 2019
Ref
* MG/JAN0001C R3
Contact
Matt Greig
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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
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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.

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To apply, please contact one of our two Senior Recruiters, either myself or my colleague Matt Greig or Theo Moore on US Toll Free >  855.505.1382  < or send a full CV to cv@advregulatory.com and we will respond by return. We are assigned these roles by our client and will provide you with support throughout the hiring process.
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About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you make that next career move on US toll free 855.505.1382

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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