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Director Of Regulatory Affairs - Cell Therapy

Regulatory Affairs, Director, Cell Therapy, Biologics, Hertfordshire

Your new company
This role is with a leading scientific consulting group of companies serving the biotechnology and pharmaceutical industry.
They are dedicated to providing high quality and competitively priced services to the biotech and pharmaceutical industries. This role is to support the Development team in providing clients with a strong Regulatory professional with experience of working on Biologics/ATMPs.

Your new role 
This role includes the need to write, review & submit clinical trial applications and associated documentation (incl. IMPDs, IBs). Strategy & Development of products, will be of considerable focus for this position, from early stage to Post-marketing.
You will be required to write and compile MAAs – Modules 1-5 (as applicable) and write or review all types of simple & complex variations.
Experience in writing and reviewing SOPs/processes and/or review sections of dossiers for Centralised/Decentralised procedures will be essential.
In addition there will be Project Management of all regulatory requirements.
You will be point of contact for agency interaction and need to provide expert EU regulatory strategy.

What you'll need to succeed

  • 2:1 (or above) graduate in relevant scientific discipline
  • 5+ years 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

What you'll get in return
Competitive Salary with excellent benefits in a strong team as a part of well developed organisation.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.


Job Type:
Life Sciences
Apply Now

Talk to a Consultant

Talk to Jack Lund, the specialist consultant managing this position, located in London City

107 Cheapside, London, EC2V 6DN

Telephone: 02034650033
For 50 years we've used our expertise to help people transform their careers.

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