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Regulatory Director / Associate Director – (ATMP)

Salary

Competitive

Location

London or Cambridge

Job Type

Full Time

Reference No: RI3349077627

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Job Description

Supporting the Development team in working on Biologics/ATMPs is the main function of this position. 

 

Location: The location is flexible, this position can be based in the UK or Barcelona with remote working and office based options

 

The Role:

  • To write, review & submit clinical trial applications and associated documentation (incl. IMPDs, IBs)
  • Strategy & Development of products, from early stage to Post-marketing
  • Write and compile MAAs – Modules 1-5 (as applicable)
  • To write or review all types of simple & complex variations
  • Write and review SOPs/processes
  • Expert regulatory documentation author (IMPDs/INDs)
  • Provide leadership in scientific advice meetings at national agencies and EMA
  • Lead EMA procedures including orphan applications, PIPs and MAAs
  • Point of contact for agency interaction
  • Provide expert EU regulatory strategy
  • Project management/lead responsibilities
  • Willing to travel
  • Confident/Enthusiastic/Outgoing
  • Ability to work on their own and to be an influential leader of a team
  • Self-motivated with excellent communication skills

Essential:

  • 2:1 (or above) graduate in relevant scientific discipline
  • Broad & deep European regulatory affairs experience with Biologics/ATMPs
  • Biologics/ATMP regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
  • Strong understanding of the regulatory environment including guidelines
  • Ability to lead team members in a matrix management environment
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Excellent computer skills

 

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

Applicant Requirements
  • Biologics/ATMP regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
  • Broad & deep European regulatory affairs experience with Biologics/ATMPs
Reference No: RI3349077627
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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