Regulatory Associate - Drug Projects
Biotechnology Clinical Pharmaceuticals
Location Abingdon, Oxfordshire
Regulatory Associate – Drug Projects
An exciting opportunity has arisen for an experienced regulatory associate to join a growing start-up at their site in Oxfordshire. 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. The regulatory associate will assist with the development and delivery of regulatory documentation for drug projects.
Some main responsibilities of the role include:
- 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
Ideally candidates will be educated to degree level (or equivalent) in relevant scientific or technical discipline. The successful applicant will have significant experience in regulatory affairs with a proven track record of writing and submitting regulatory documentation, and will be able to build strong relationships and work collaboratively both with internal team members and external CRO partners.
This is a great opportunity to join a growing company who have received significant backing, and have a real impact in shaping the company. If this sounds like the opportunity for you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.