Regulatory Associate – Drug Projects
Life Sciences Pharmaceuticals
CY Partners have an exciting opportunity for a Regulatory Associate to join an expanding innovative company based in Oxford.
As a Regulatory Associate, you will play a critical role in successfully delivering innovative drug development projects. Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed regulatory strategies.
Other responsibilities include:
• Working alongside the quality and technical leads write regulatory clinical trial documentation for submission to EU/US.
• Preparing Clinical Trial Authorisation (CTA/IND) submissions and substantial amendments to competent authorities and ethics committees.
• Preparing and reviewing clinical trial associated documentation (including IMPDs, IBs, EudraCT, protocols and labelling)
• Preparing briefing documentation for scientific advice meetings with EU/US regulatory authorities (including pre-IND, EOP2, pre-NDA)
• Reviewing pertinent regulations and guidance to develop pro-active solutions to regulatory issues and challenges.
• Interacting with regulatory agencies writing and submitting orphan drug applications, PIPs, LPAD submissions etc.
For further information please feel free to contact Helen at CY Partners on 0191 477 4733 or [email protected]