Director of Pharmaceutical Compliance

4 days ago


Cambridgeshire and Peterborough, United Kingdom Cpl Healthcare Full time

Cpl Healthcare collaborates with a reputable global consultancy firm.

The company specializes in supporting pharma, biotech, spin-out, and academic groups with drug development activities.

This includes advanced therapies, cell therapy, ATMPS, and other niche therapeutic areas.

Role Overview:

The Senior Director of Regulatory Affairs will lead client projects, providing strategic regulatory advice.

  • Gap analyses, filing routes, regulatory interactions, and designations.
  • Prepare regulatory submission documents, including orphan drug designation applications.
  • Clinical trial applications and marketing authorisation applications.

Main Responsibilities:

  1. Lead regulatory agency interactions/negotiations.
  2. Manage complex regulatory projects, mitigating risks.
  3. Provide leadership to a team of 4 regulatory affairs professionals.
  4. Support development plans, offer training, and mentor regulatory staff.
  5. Contribute to regulatory intelligence, maintaining up-to-date knowledge.

Qualifications:

  1. At least 12+ years in Regulatory Affairs within a complex therapeutic area.
  2. Experience with EMA (scientific advice, orphan designation, PIPs).
  3. Experienced in driving global Regulatory Affairs Strategies.
  4. Willingness to work hybrid, with an office presence (2/3 days on-site per week).


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