Regulatory Affairs Senior Associate / Associate Manager - CTA

2018-10-16 09:44:492019-12-17LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 40,000 ~ 52,000 Annual Rate
Job Ref0065800000UVO7HAAX
Job Views514
Description

Based at a growing organisation, working on a wide scope of products and therapy areas, this key partner of ours 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. 
  • ExperienceGraduate 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

Reports to: Regulatory Affairs Senior Manager


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

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To find out more about Linkfield Life Sciences Ltd, and how we can partner with you to support your Regulatory Affairs recruitment requirements, please contact us below:

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Office 2b
Mercury House,
High Street,
Tattenhall, TN8 6EN

  • 0207 183 5059
  • info@linkfieldgroup.com
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