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 07851246847 or [email protected]