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Senior Regulatory Affairs Associate - Global CRO

Senior Regulatory Affairs Associate - Global CRO

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    22981_1614943752

  • Published:

    5 months ago

  • Expiry date:

    2021-04-04

  • Consultant:

    #

Job title: Senior Regulatory Affairs Associate

A CRO with offices based in London are seeking a Senior Regulatory Affairs Associate to join their global team. You will be working with local and international teams supporting clinical development across a range of therapy areas such as Oncology, Cardiology, Metabolic Disease, and Endocrinology.

Responsibilities:

  • Preparation and delivery of regulatory submissions to domestic and international regulatory agencies.
  • Maintain timelines for components of regulatory deliverables.
  • Perform document quality control checks in accordance with established processes.
  • Maintain and train on up-to-date regulatory requirements, guidance and science; and may be responsible for other projects and responsibilities as assigned.

Requirements:

  • Bachelor's Degree in a related field; advanced degree highly preferred (M.D., Pharm.D, Ph.D.)
  • Experience of the EMA Paediatric Investigation Procedure and Investigational Brochure would be an advantage.
  • Good Regulatory Affairs experience in the Biotechnology, Pharmaceutical or CRO industries is essential.
  • Knowledge of EU procedure, ODD and Scientific Advice.

Salary and benefits:

A competitive annual salary and benefits package is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk