REGULATORY GRL - have US NDAs/ s/NDAs? Want to move up to a GRL role? Raleigh, Durham/ RTP/North Carolina (code USA 140920-2)

Reference: TM140920B

Expiry Date: 14-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Durham County
United States

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Job Description

REGULATORY GRL - have US NDAs/ s/NDAs? Want to move up to a GRL role? Raleigh, Durham/ RTP/North Carolina

My client is seeking an individual who has at the very least, a good understanding of global drug development and registration (through involvement in project teams) and who now feels it is right to step up to a global regulatory leader role!

You will take over a submission preparation team, pre-submission, and take another indication through global filing, in a company where the GRL role sits with commercial, and supports directly the commercial and development leads.

The company has a strong pipeline, is led by experienced and well-known individuals who have a pedigree for development of their people and regulatory teams, that said, you will spend most of your time directly with the commercialization folks, and with your regulatory sub-teams.

The role is for someone who is able to manage the expectations of commercial and development partners while identifying opportunities with the business to bring both new markets and new indications to patients more quickly. After working on this high profile product, you will transition to a new NBE or recently registered product to work on a new set of life-cycle strategies (those with clinical studies dependant).

I would readily want to hear from you if you have relevant filing and approvals experience in the US  with / without international, and think this is the right step for your career.

You want to work on a Blockbuster to lead its final 2 clinical indications / label extensions before moving to another NME or new product:

  • You like working in paediatrics or geriatric patient segments!
  • Experience in CNS or Neuro, Orphan, Seizure or Stroke useful
  • Director or Associate Director role
  • Comes with a bonus and RSU stock scheme
  • Well-known biopharma easily commuted from within the Raleigh, NC area, with some home working available (relocation available for the right candidate).

To Apply!

To apply for this role, please press the red “Apply for position”, or contact Theo Moore or Matt Greig on US toll free  855.505.1382.

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