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CMC Regulatory Affairs Associate

3 months ago

Uxbridge, United Kingdom Park Street People Full time

Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Associate to join their team in Uxbridge.


Working in a busy global department, there is a focus on working together to achieve results. You would be joining a company with an exciting pipeline who are continually developing their drug portfolio.


This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.


Key Responsibilities

  • A key role in the execution of CMC regulatory strategies working on multiple cross functional projects
  • Putting together and altering dossiers as well as electronic dossier/document management
  • Working on CMC submissions
  • Liaise with and build good relationships with affiliates, sites, regulatory agencies and other internal and external stakeholders
  • Maintain an active awareness of EU and EMEA Regulatory legislation


Requirements

  • Previous experience in UK/EU regulatory affairs or a background in quality control/assurance
  • CMC experience, specifically working on CMC submissions for clinical trials and marketing applications
  • Exposure to Regulatory Affairs legislation and procedures
  • Degree educated or demonstrable knowledge in biochemistry or chemistry highly advantageous
  • Strong communication and interpersonal skills


Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.