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Regulatory Affairs Senior Associate / Associate Manager - CTA

Salary

£40,000 - £52,000

Location

North London

Job Type

Full Time

Reference No: RI3349077625

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Job Description

Based at a growing organisation, working on a wide scope of products and therapy areas, this key partner of Linkfield Life Sciences 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.

Experience

  • 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.

Reports to: Regulatory Affairs Senior Manager

 

For further information contact Natalie Hopkins on 0207 183 5059 or email natalie@linkfieldgroup.com

Applicant Requirements
  • Strong attention to detail
  • Self-motivated with excellent communication skills
  • Good computer skill
  • Ability to work under pressure and achieve timely submission and regulatory approvals
Reference No: RI3349077625
Linkfield Life Sciences are a Regulatory Affairs Recruitment Partner, working with organisations across the Life Sciences sector.

Hiring Manager(s)

Natalie

Head of Regulatory Affairs Recruitment at Linkfield Life Sciences
email: natalie@linkfieldgroup.com

Email Natalie

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