English Consultant

4 weken geleden


Breda, Noord-Brabant, Nederland Scendea Voltijd
Principal Consultant (CMC) Job Description

We are seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC).

About the Role

This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy.

You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.

Responsibilities
  • Provide strategic, technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
  • Provide innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
  • Contribute 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 according to area of expertise.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
  • Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
  • Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
  • Line manage, train, and mentor 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 (e.g., a life/physical science focused MSc or preferably a PhD).
  • 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.
About Scendea

Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide.

We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service.

With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base.

Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged.


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