The role of Regulatory Associate, Drug Projects 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.
-Working alongside the quality and technical leads writing 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.
-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
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46766 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Amy Lloyd
- Phone: 01438 743047
- Reference: 46766
- Posted: 10th October 2019
- Expires: 7th November 2019