Senior Regulatory Affairs Director

1 month ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

At Clinical Professionals Limited, we are collaborating with a prestigious global drug development consultancy business. This esteemed organisation specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. They have a specific focus on advanced therapies, cell therapy, ATMPS, and other niche and challenging therapeutic areas.

The Senior Director of Regulatory Affairs will provide support to the Regulatory Affairs team across a range of projects. Working closely with the Vice President of Regulatory Affairs, this individual will oversee the team.

  • This role entails leading client projects, offering strategic regulatory advice, taking into account regulatory guidelines, and available measures to facilitate regulatory input, incentives, and early market access. This includes activities such as gap analyses, advice on filing routes, timings, regulatory authority interactions, paediatric development, orphan drug designation, and PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications.
  • The successful candidate will be responsible for preparing regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications, investigational new drug applications, PIPs/PSPs, PRIME/BTD/RMAT, and marketing authorisation applications.
  • This position involves providing leadership to a team of 4 regulatory affairs professionals, supporting development plans, offering training and development to the whole team.
  • The Senior Director will lead regulatory agency interactions/negotiations to ensure client goals are met.
  • This role also includes completing senior QC review as required.
  • The individual will lead on complex, multifactorial regulatory projects requiring input from several functions, highlighting and mitigating potential risks to timelines, budget, and deliverables for clients.
  • This position requires resolving internal/external project issues as needed, with escalation to senior management where required.
  • The Senior Director will work with the Quality function to ensure applicability and compliance for regulatory affairs activities.
  • The ideal candidate will have at least 12+ years in Regulatory Affairs within a complex therapeutic area.
  • Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is essential.
  • Driving global Regulatory Affairs Strategies is a key requirement.
  • The individual must have experience of directly working with national regulatory agencies and leading agency meetings face to face.
  • A willingness to support all ongoing projects and business activities as required, including mentoring and line management of regulatory staff as appropriate.
  • The successful candidate will also contribute to the company's regulatory intelligence function by maintaining up-to-date regulatory knowledge.

We offer an excellent opportunity to join a growing organisation at the heart of drug development. The salary for this position is £130,000 + benefits, which is negotiable based on experience. An office presence is expected, with a minimum of 2/3 days on-site per week, due to the leadership nature of the role.



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