CMC Regulatory Affairs Manager

3 weeks ago

Uxbridge, United Kingdom Park Street People Full time

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


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
  • Oversee all regulatory submissions as well as reviewing and altering dossiers as necessary ensuring that these are compliant
  • Liaise with and build good relationships with affiliates, sites, regulatory agencies and other internal and external stakeholders
  • Maintain an active awareness of EU and EEMEa Regulatory legislation


Requirements

  • Previous experience in international Regulatory Affairs and Compliance particularly within the pharmaceutical industry
  • Full regulatory lifecycle process experience highly advantageous
  • Good understanding of regulatory procedures such as CTAS, marketing authorisations and post approval
  • Strong communication and stakeholder engagement skills
  • Proactive manner


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.

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