Expiry Date: 02-05-2021
Categories Clinical Research, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Raleigh / Durham / RTP, NC ** US Regulatory Liaison ** Manage an indication for Ph 3 then join a NDA filing team
My client is seeking a mid-level regulatory project manager (grade can be Manager, Sr Manager) and wants to join a team which is developing a NME with high unmet need in paediatrics, to initially manage a Ph 3 IND and Clinical Study program as the Regulatory lead, then input into a new indication design and new IND, before preparing the NME for NDA and s/NDA filing. You will be responsible for managing FDA contacts and meetings and acting as US Liaison.
You will be mentored by 2 individuals, in this role, 1 will be the Team Director who has a great deal of experience in managing people and developing individuals up, and the Global Regulatory Lead, who will help you develop better understanding of overall RA strategy and bring you into the global mind-set so you can further develop your thinking.
You will have previous regulatory affairs experience, including working on but not limited to, INDs, Paediatric Studies, s/NDAs or fill NDAs, other Line Extensions as well as some experience in working with the US FDA.
The organization pays generally pretty well, with decent bonuses based on merit which can be over achieved personally and with a company multiplier. The company is based in RTP and they do allow some home working after induction.
To apply for this role, please press the red “Apply for position” button, or contact Matt Greig or Theo Moore, on 908-332-9157 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs. Please feel free to call me during working hours or on Saturday or Sunday AM (Eastern time).
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