Regulatory Senior Expert

7 hours ago


Hertfordshire, United Kingdom Leaman Life Sciences Full time
Job Role Overview

Leaman Life Sciences is seeking a highly experienced Regulatory Senior Expert to join their team in Hertfordshire. The ideal candidate will have a strong background in non-clinical development of human medicinal products and a proven track record of providing strategic, technical, and regulatory advice to clients.

The successful candidate will be responsible for providing innovative drug development plans, data gap analyses, and international regulatory strategies from a non-clinical perspective for complex products within the changing regulatory environment. They will also be expected to establish and maintain a high level of technical knowledge within product development and international regulatory affairs.

Key Responsibilities

  • Provide strategic, technical, and regulatory advice/services to clients with a special interest in non-clinical development of human medicinal products.
  • Develop and implement innovative drug development plans, data gap analyses, and international regulatory strategies from a non-clinical perspective.
  • Establish and maintain a high level of technical knowledge within product development and international regulatory affairs.
  • Represent clients in all regulatory agency interactions and provide regulatory solutions to agency objections.
  • Contribute to technical authorship and review of development regulatory documents.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
  • Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
  • Support the Business Development team in sales/marketing introductions and generate additional business from current clients.
  • Line manage, train, and mentor members of the Operational team.

Requirements

  • A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent.
  • A minimum of ten years of drug development experience (Principal Consultant) or minimum eight years of experience (Senior Consultant).
  • A minimum of ten years of experience (Principal Consultant) or a minimum of eight years (Senior Consultant) with either FDA, MHRA, and/or EMA, including negotiation.
  • Experience with either recombinant proteins (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products (tissue, cell and gene therapy) and NCE and/or generic chemical entities.
  • Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.
  • Proven ability and willingness to lead a team and deliver education and training in chosen field.

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