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Senior Regulatory Executive

3 months ago

Croydon, United Kingdom Pfizer Careers Full time

Company description:

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. Were looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Job description:

  • Contribute to Cross-functional Teams and Build Regulatory Expertise.
  • Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
  • Manage and Submit Marketing Authorisation Applications
  • Management of Safety Reports and Issues with Regulatory Authorities
  • Influence Regulatory Authorities
  • Manage Clinical Trial Approvals
  • Populate and Maintain Regulatory Databases
  • Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use
  • Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
  • Implement MA Divestments, Cancellations and product Discontinuations
  • Contribute to Good Regulatory Practice (appropriate for all tasks)
  • Support Regulatory Group Development
  • Lead Personal Development
  • Support to Third Party Licences
Required profile:

  • Life sciences or chemistry graduate to honours level or equivalent
  • Masters Degree, Post Graduate Diploma or PhD preferred