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Regulatory Officer

Regulatory Officer

Job Title: Regulatory Officer
Contract Type: Contract
Location: Oxford, Oxfordshire
Industry:
Salary: Negotiable
Reference: RO102_1501151837
Contact Name: Alastair McCartney
Contact Email: a.mccartney@sciproglobal.com
Job Published: July 27, 2017 11:37

Job Description

REQUIREMENTS
* Technical expertise in managing regulatory aspects of clinical studies in the UK
* At least two years' experience in Regulatory Affairs for clinical research and
knowledge of local regulatory environment
* University degree in Life Sciences or Pharmacy
* Excellent command of English (spoken and written)
* Excellent communication, planning and organizational skills
* Demonstrated ability to multi-task and work effectively in a fast-paced
environment
* Proficiency in standard MS Office applications
RESPONSIBILITIES
* Liaising with clinical project teams to procure documents required for regulatory
& ethics submissions
* Preparation of regulatory and ethics committee submission dossiers
* Tracking regulatory project documentation flow and progress reporting
* Tracking changes/amendments to legislation requirements related to clinical
research
* Maintaining the database of regulatory requirements
* Communication point for ethics committees and regulatory authorities
* Ensuring accurate and timely reporting to ethics committees and regulatory
authorities;
* Communication line for clinical Project Teams and support services on
regulatory matters
* Delivering regulatory-related training, as required