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Senior Regulatory Specialist

South East, England, United Kingdom Full-time Posted 2 weeks ago

Our client, a leading global consumer healthcare organisation, is looking for a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team (hybrid working).


This is a fantastic opportunity for an experienced regulatory professional to take ownership of a broad and varied portfolio, working across EU regulatory procedures and playing a key role in maintaining and expanding a well-established medicinal products portfolio.


What You'll Be Doing

  • Leading on regulatory submissions in line with EU requirements (MRP/DCP), ensuring the ongoing maintenance and compliance of existing marketing authorisations
  • Managing non-CMC lifecycle activities, including variations, renewals and safety updates
  • Collecting and evaluating regulatory, quality, preclinical and clinical data to support compliance
  • Liaising directly with Health Authorities, proactively seeking opportunities to expedite approvals
  • Prioritising and managing multiple projects against agreed timelines
  • Ensuring all assigned products remain compliant with local regulatory and quality requirements
  • Supporting internal audits and inspections
  • Partnering cross-functionally to manage crises and sensitive regulatory issues
  • Driving local process improvements within the regulatory function


What We're Looking For

  • A relevant Bachelor's degree or higher
  • Significant experience within a Regulatory Affairs , ideally within non-prescription EU procedures (MRP/DCP)
  • Proven track record managing non-CMC lifecycle activities and safety updates
  • Strong attention to detail and excellent organisational skills
  • Confident communicator, able to simplify complex regulatory topics for varied audiences
  • A collaborative mindset with a strong sense of ownership and accountability
  • Comfortable operating in a fast-paced, matrixed, multicultural environment
  • Fluent in English


Desirable:

  • Experience within the consumer healthcare sector
  • Understanding of cross-functional processes within a healthcare organisation


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