Regulatory Associate, Drug Projects

Sep 15, 2019

OXFORD | FULL TIME

The role of Regulatory Associate, Drug Projects at 30 Technology is 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. 

This role is a great career opportunity for a drug development Regulatory Associate who is highly motivated to succeed and enjoys the fast-moving pace that a small biotech company brings. We are looking for an experienced regulatory affairs specialist to assist with the development and delivery of regulatory documentation for drug projects.

This role is based in Oxford, UK.


RESPONSIBILITIES

  • Working alongside the quality and technical leads write regulatory clinical trial documentation for submission to EU/US

  • Prepare Clinical Trial Authorisation (CTA/IND) submissions and substantial amendments to competent authorities and ethics committees

  • Prepare and review clinical trial associated documentation (including IMPDs, IBs, EudraCT, protocols and labelling)

  • Prepare 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

  • Interaction with regulatory agencies writing and submitting orphan drug applications, PIPs, LPAD submissions etc.


ESSENTIAL REQUIREMENTS

  • Bachelor’s degree in a scientific or technical subject

  • 5 years+ experience in regulatory affairs with a proven track record of writing and submitting regulatory documentation

  • Excellent written and verbal communication skills.

  • Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners


APPLICATION DETAILS

To be considered for this exciting opportunity, please submit your CV and a cover letter to jenny.howell@30.Technology

Closing date: 15th October 2019

30 Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.

30 TECHNOLOGY Therapeutic Nitric Oxide