Regulatory Affairs Officer

  • Permanent
  • Berkshire
  • Negotiable GBP / Year

Job title: Regulatory Affairs Officer

A small pharmaceutical company in Berkshire with upcoming product launches are seeking a Regulatory Affairs Officer. Reporting into the Head of Regulatory Affairs, this role offers excellent career development across UK and EU markets. This role is office based 1 day per week.

Responsibilities:

  • Prepare and deliver regulatory operational plans for assigned projects/products
  • Updating of Module 1 (Module 1 of the CTD) in order to assist in the preparation of dossiers for MA application
  • Preparation and submission of variations to the MHRA
  • Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL)
  • Responsible for UK specific regulatory oversight on marketed products

Requirements:

  • Degree in pharmacy, life science or a recognised healthcare professional degree/qualification.
  • Good knowledge of Regulatory legislation where appropriate
  • Practical experience in interacting with and influencing the MHRA
  • Experience in process mapping and writing process documents and driving continuous improvement

Salary and benefits: A competitive salary, annual bonus and wider 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

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