Regulatory Affairs Manager

2018-10-16 09:44:492018-11-13LinkField Life Sciences
Job TypePermanent
AreaCentral London, UK
SectorPharma / Biotech
Salary£ 58,000 ~ 65,000 Annual Rate
Job Ref0065800000jI5lHAAS
Job Views909
Description

 We are currently partnering with a exciting organisation who are looking to expand their Regulatory Affairs Management Team. Working largely on Post Marketing / Post Approval and CMC activities this position will be a key Project Lead. There is also the opportunity to line management more junior Regulatory staff if desired.

General Responsibilities:

  • Management of Regulatory project work/project lead
  • Preparation and coordination or review of documentation or dossiers
  • Regulatory strategy (pre-submission or post-approval stages)
  • Maintaining an awareness of the EU Regulatory landscape and changing regulatory requirements


Key Responsibilities:

  • Preparation and project management of Marketing Authorisation Applications (MAA)
  • Authoring of CMC documents and/or complete Module 3s
  • Coordination of preparation of m2, m4 and m5 for MAAs
  • Preparation and review of responses to questions
  • Preparation and review of post-approval submissions
  • Dossier reviews and gap analyses
  • Assisting with Scientific Advice procedures

 

Professional Experience:

  • 2:1 (or above) graduate in a relevant scientific discipline
  • Broad & deep regulatory affairs experience
  • Strong understanding of the EU regulatory environment including guidelines
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Ability to analyse issues and propose solutions



To apply please send your CV through to 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:

WE’RE EASY TO FIND

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

  • 0207 183 5059
  • info@linkfieldgroup.com
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