Regulatory Expert Consultant

3 dagen geleden

Breda, Noord-Brabant, Nederland Scendea Voltijd
Job Description:

We are seeking a highly skilled Principal Consultant (CMC) to join our team. As a key member of our global consulting group, you will play a vital role in delivering high-quality regulatory technical advice and product development strategies to clients.

The ideal candidate will have a strong scientific background, with a relevant degree in a biomedical field or equivalent. You should have direct experience in providing strategic regulatory planning from early-stage development up to marketing authorisation, as well as a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.

Your responsibilities will include:
  • Providing strategic, technical and regulatory advice/services to clients.
  • Developing innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
  • Contributing to technical authorship and review of development regulatory documents, including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs.
  • Leading multi-jurisdiction programs of work and delivering consulting services within your respective area of expertise.
  • Leading meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
  • Servicing Scendea's Business Development in sales/marketing introductions and generating additional business from current clients.
  • Line managing, training, and mentoring members of the Scendea Operational team, including providing technical leadership.

Requirements:
  • A high scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent.
  • 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, both internally, and at scientific conference presentations.
  • High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.

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