Job Posted: 18 Jan 2017

Regulatory Affairs Associate - Oxford

35k - 38k pa| Oxfordshire| Permanent

An excellent opportunity has arisen for a Regulatory Affairs Associate to join a growing Pharmaceutical company based in Oxfordshire on a permanent basis. Within this role you will be responsible for supporting registration and maintenance of products across Europe.


*Support the preparation, review, and submission of regulatory submissions as appropriate, (i.e: including marketing applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports).
*Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for regulatory submissions
*Manage timelines to support timely approvals and development objectives
*Manage review tracking systems for regulatory documents and promotional materials
*Enter data into Regulatory Database

Essential Qualifications:

*BS/BA with a minimum of two to four years of regulatory experience
*Fluency in English language: written and verbal communication skills
*Basic understanding of regulations and guidelines for drug or biologics development
*Ability to work independently
*Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners
*Soft skills such as detail-oriented, able to multi-task
*Experience with electronic submissions (eCTD)
*Understanding of the CNS, and/or oncology therapeutic areas is desirable

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on [Phone number removed] or email a copy of your CV to [Email address removed]