Job Reference: WS123
- Breda, Noord-Brabant
- £65900 - £105400 per annum
- Permanent / Full Time
Seven Life Science have an amazing opportunity available as a Principal Consultant, this role is based in Breda, North Brabant, Netherlands.
- Seeking a highly motivated individual as a full-time Principal Consultant (clinical focus) to join our newly established Netherlands office.
- 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 in the newly established Netherlands office, as part of the global team.
- Hybrid working – couple days a month in office.
- 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
- 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 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 the consultancy team, including other Principal and Senior Consultants
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise
- 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
- 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
- Line manage individual contributors, and in doing so, provide ongoing coaching and mentoring
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). MD qualification would be advantageous but is not essential
- 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, Bishop’s Stortford on at least a quarterly basis
- A competitive salary, which is commensurate with experience
- Generous bonus program, which rewards success
- 26 days’ vacation plus discretionary additional days for birthday and work anniversary and public holidays
- 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
Working with Seven Life Science:
We have been helping professionals find exciting new roles for almost a decade, so we know exactly where to look when it comes to sourcing the best opportunities. We operate across the UK, and, with over 300 five-star reviews, multiple awards and amazing relationships with the biggest employers in UK Life Science, we give you the best chance of landing your next role.
We have a reputation for recruiting at lightning speed, however, we can only respond to candidates who meet the exact requirements of the position. If you have any queries about a role or application, please visit our website where our amazing candidate support team will be more than happy to help.