I am working with my client, who have a superb opportunity for a highly motivated Principal / Senior Consultant (Non-Clinical) to their to join their extremely successful and rapidly growing Regulatory Consultancy If you are looking to grow your career, playing a key role within the team, developing and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for their clients, this could be just the role for you!
Key Requirements Providing strategic, technical and regulatory advice/services to clients with a special interest in non-clinical development of human medicinal products.
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.
Establishing and maintaining 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 including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, IMPDs, CSRs, MAAs, NDAs BLAs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, according to area of expertise.
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.
Lead meetings with stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
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, including providing technical leadership.
Skills and Experience A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD).
Non-clinical (ideally toxicology) educational background is a prerequisite for this position.
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.
Regulatory experience may include time within a National Competent Authority.
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, both internally, and at scientific conference presentations.
This role requires a minimum of one day a month in the offices in Hertfordshire and a willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.