Senior Regulatory Affairs Associate - London

  • Job Reference: CR8776-RA
  • Date Posted: 20 September 2019
  • Recruiter: gel Resourcing Ltd
  • Location: London
  • Salary: £35.00 to £100 Per Hour
  • Sector: Pharmaceutical
  • Job Type: Contract, Permanent
  • Work Hours: Full Time
  • Contact: Chris Rose
  • Email: crose@gelresourcing.co.uk
  • Telephone: 01323 332355

Job Description

Our client is a leading Pharmaceutical company based in W.London

Main Responsibilities and Duties:

  • Prepare and submit clinical trial applications and substantial amendments to competent authorities and ethics committees throughout Europe.
  • Preparation of submissions using IRAS and EudraCT systems
  • Review and extract information from clinical trial associated documentation (incl. IMPD’s, IB’s, EudraCT, Protocols & labelling)
  • Quality Control check junior member of staff work, correct where necessary & provide feedback.
  • Write, review and implement SOPs/processes
  • Be responsible for Clinical Trial Management Plans & interaction with clients for CTA related activities.
  • Client Facing with strong communication skills, willing to travel if required

Qualifications and Skills

Essentials:

  • 2:1 (or above) graduate in relevant scientific discipline
  • 4+ years broad Clinical Trials Experience, covering competent authority and ethics submissions
  • Experience with IRAS system and HRA process for UK submissions
  • Strong understanding of the regulatory environment for Clinical Trial Applications
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Good computer skills