Regulatory Affairs Principal Consultant (Clinical)
- Full time
- Herts/Essex area
- Hybrid – 1 day per month minimum office based
- Excellent remuneration and benefits offered
My client is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Their 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. They are seeking a full time permanent member of staff to join their team. 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 in the area of clinical development of human medicinal products, across a wide range of therapeutic indications
- Offer support and advice across a broad range of regulatory activities
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment
- Support the Business Development team 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 the consultancy team, including line manage individual contributors, and provide ongoing coaching and mentoring 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 Directors and the company’s growth plan
- Mentoring and training junior members of the consultancy team (including Senior Consultant, Consultant and Associate levels)
- Represent the company at seminars, conferences, and events
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)
- At least fifteen years of drug development experience, with at least five years in the area of biotechnology and regulatory affairs
- Clinical development experience across a range of therapeutic indications/disease areas
- Preference for candidates with significant experience in drug development covering Europe, UK, and the United States
- 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, on at least a quarterly basis
