Regulatory Affairs Leadership Opportunity

1 day ago


Cambridgeshire and Peterborough, United Kingdom Cpl Healthcare Full time
Job Title:

Senior Director, Regulatory Affairs

Remuneration: £130,000 + Benefits per annum in Cambridge, UK (hybrid role)

Cpl Healthcare collaborates with a renowned global drug development consultancy business supporting pharma, biotechs, spin-outs, and academic groups.

Key Responsibilities:
  1. Lead client projects providing strategic regulatory advice on gap analyses, filing routes, regulatory interactions, and designations.
  2. Prepare regulatory submission documents including orphan drug designation applications, clinical trial applications, and marketing authorisation applications.
  3. Provide leadership to a team of 4 regulatory affairs professionals supporting development plans and offering training.
  4. Lead regulatory agency interactions/negotiations ensuring client goals are met.
  5. Manage complex regulatory projects mitigating risks to timelines and budgets.
  6. Draft cost proposals and manage project budgets.
  7. Resolve internal/external project issues escalating to senior management as needed.
  8. Work with the Quality function to ensure compliance in regulatory affairs activities.
Requirements:
  • At least 12+ years in Regulatory Affairs within a complex therapeutic area.
  • Experience with EMA (scientific advice, orphan designation, PIPs).
  • Experienced in driving global Regulatory Affairs Strategies.
  • Experience working with national regulatory agencies and leading agency meetings.
  • Willingness to support ongoing projects and business activities, including mentoring regulatory staff.
Additional Information:

This role requires an office presence (2/3 days on-site per week) due to its leadership nature.

The successful candidate will have experience working in a fast-paced environment and will be able to motivate a team towards achieving company objectives.



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