Regulatory Affairs Senior Associate / Associate Manager – CTA

Salary

£40,000 to 52,000 Annual Rate

Location

North London

Job Type

Permanent

Reference No: 0065800000UVO7HAAX

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Job Description

Based at a growing organisation, working on a wide scope of products and therapy areas, this company is looking for a Regulatory professional with strong CTA experience.

Responsibilities:

  • Prepare and submit Clinical Trial Authorisation (CTA) applications and substantial amendments to competent authorities throughout Europe.
  • Assist with managing workload of clinical trial team and prioritisation decisions.Review and extract information from clinical trial associated documentation (incl. IMPDs, IBs, EudraCT, Protocols & labelling)
  • Quality control check junior member of staff work and contribute to their training.

Reports to:

  • Regulatory Affairs Senior Manager

For further information contact Natalie Jones on 0207 183 5059 or email [email protected]

Applicant Requirements
  • Graduate in relevant scientific discipline
  • Broad Regulatory CTA experience covering a range of EU countries
  • Experience in preparing submissions for both competent authority and ethics committees
  • Experience with IRAS system and HRA process for UK submissions
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Good computer skill
  • Self-motivated with excellent communication skills
  • Strong attention to detail

Reference No: 0065800000UVO7HAAX

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Hiring Manager(s)

Natalie Jones
+44(0)207 183 5059