Regulatory Associate – Drug Projects

Regulatory Associate – Drug Projects

Life Sciences Pharmaceuticals

Location Oxford

Salary Competitive

Contract Permanent

Reference HMR24DP

Date Posted


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]

Regulatory Associate – Drug Projects

Life Sciences Pharmaceuticals

Apply now

1 week left to apply

Quick Apply

Already a member?

Yes, send me relevant communications
I accept the terms and conditions and privacy policy of CY Partners.

Related Vacancies

Pharmaceutical Releasing Officer – Aseptics

Biotechnology Chemical Life Sciences Pharmaceuticals

LocationCounty Durham

SalaryUp to £20,000 + Benefits


CY Partners are currently looking to recruit an Aseptic Releasing Officer on behalf of a County Durham based Pharmaceutical Manufacturer. The main purpose of this role is to perform a range of…

Laboratory Analyst




A global health care leader, based in the Newcastle area, are looking to recruit a Laboratory Analyst on an initial 6 month fixed-term contract. The client in question have a diverse portfolio…

Project Manager

Biotechnology Chemical Clinical Life Sciences

LocationSouthern England



A unique opportunity has become available for Project Manager, with a leading pharmaceutical development organisation. Boasting state of the art pilot and large-scale process development facilities in southern England, the organisation brings…