REGULATORY GRL - have US NDAs/ s/NDAs? Want to move upto a GRL role? Greater Atlanta, Georgia
Please read the following and it this resonates with you then please apply to me, Matt Greig, or Theo Moore on to 855-505-1382 - please feel free to call us during working hours or on Saturday or Sunday AM (Eastern time)!
Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
You want to work on a Blockbuster to lead it's 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 Atlanta, Georgia area, with some home working available (relocation available for the right candidate).
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 Europe with / without international, and think this is the right step for your career.
To apply for this role, please send your CV to CV@AdvTalent.com, or contact Theo Moore or Matt Greig on US toll free 855.505.1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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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.
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