We are a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Our international team offers strategic and operational support in the fields of CMC, nonclinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval. With a current team of over 50 staff based in the UK, Ireland, the Netherlands and the US, we are 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 its rapidly growing client base.
The Role
We are seeking a highly motivated individual to join our global team as a full-time Principal Consultant (Non-clinical). 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.
Key Objectives
- Provide strategic, technical and regulatory advice/services to clients with a special interest in non-clinical development of human medicinal products
- Experience shall ideally include 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
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a non-clinical perspective for complex products within the changing regulatory environment
- Support Business Development in sales/marketing introductions, preparation of project proposals & educational materials, review written estimates, quotations and contracts for Clients as required
- 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, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise
- Provide technical leadership to other members of our consultancy team, including other Principal and Senior Consultants
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise
- Represent our clients in regulatory agency interactions and provide regulatory solutions to agency objections
- Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets
- Generate additional business from current Clients through exceeding expectations relating to the quality, delivery time and cost of services, and empower others to do the same
- Educate clients on current regulatory trends and expectations. Where relevant champion the client’s view for development of products with other contractors such as CROs
- Establish and maintain a high level of technical knowledge in the area of product development and international regulatory affairs
- Support the development and operation of the alliance network and new partnership opportunities
- Challenge the regulatory ‘status quo’ from a technical and scientific standpoint
- Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities
- Provide strategic input/support to the Directors and the company’s growth plan
- Line manage individual contributors, and in doing so, provide ongoing coaching and mentoring
- Mentoring and training junior members of the consultancy team (including Senior Consultant, Consultant and Associate levels)
- Represent the company at seminars, conferences, and events
Location & Reporting Structure
- The role will be affiliated to our UK office in Hertfordshire
- The role will be flexible, working from home with a minimum of one office-based day per month
- The selected candidate will report directly to Principal Consultant
- The role includes Line Management responsibility
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
- At least fifteen years of drug development experience. Regulatory experience may include time within a National Competent Authority (preferable)
- Preference for candidates with significant experience in drug development covering Europe and the United States
- Particular interest for candidates who are European Registered Toxicologist (ERT) but this is not essential
- Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues
- Preference for candidates who have direct experience in providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation
- Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK and US authorities.
- Proven ability to deliver education via scientific conference presentations in chosen field and training of subordinates
- A professional manner and presentable appearance for meeting customers/clients
- Ability to work in a proactive and autonomous manner as well as leading a global team, to ensure high-quality of deliverables
- Ability to balance competing priorities and complete work within a set timeframe
- Exemplary organisational skills with a high level of attention to detail
- Exemplary verbal communication and presentation skills in English
- High level of computer literacy and competency in MS Office programs
- Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally, with travel to the UK office
Benefits
- A competitive salary, which is commensurate with experience
- Generous bonus program, which rewards success
- 26 days Holiday plus Birthday and Work Anniversary
- 5% employer pension contribution
- Compensation of Private Healthcare insurance
- Access to Employee Assistance Programme
- Employee Ownership Trust Scheme
- An opportunity to influence global business strategy, and associated implementation
- A challenging and stimulating position for a dynamic and competent regulatory professional, who wishes to contribute to a growing business and a rapidly expanding team
- Coaching and mentoring to support your continuous development
- A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation
