Principal Clinical RA Consultant

Our client, a growing international biotech consultancy, is expanding its team in The Netherlands and looking for a Principal Clinical RA Consultant. As part of the starting group in the Netherlands, you will witness positive changes firsthand and have the opportunity to grow with the company, taking on more responsibilities quickly. Worldwide the company has around 50 employees, which means you will know all your colleagues personally, fostering a close-knit and valued work environment that ensures faster responses and results.

Benefits:

- Be part of a consultancy that values collaboration, providing HR, admin support, and sales assistance to RA consultants. This allows you to focus on the scientific and technical aspects of the job, enabling you to delve deeper into research and even contribute to articles or scientific papers.

- Engage in projects focused on drug development for various pharma and biotech clients, allowing you to be at the forefront of innovation and gain insights into multiple companies' endeavors.

Responsibilities:

• 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 Contribute and review of development regulatory documents Represent the clients in regulatory agency interactions and provide regulatory solutions Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets Mentor and train more junior consultants in the team

Requirements

• Master Degree or PhD in life sciences (confirmation will come in which direction more pharma/chemistry OR more micro, molecular or cellular biology/immunology)
• 10+ or 15+ years of experience in clinical development and early drug development
• Broad experience in a lot of different clinical documentation (also RA related) like 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
• People management experience is a plus but not required if they want to mentor more junior consultants in the team
• Experience on the international level so understanding and connections in the relevant authorities like EMA, FDA, Health Canada, Japan,...
• Fluent level of English, other EU languages a plus

If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About the hiring agency: Our client has partnered with NonStop, a leading provider of staffing solutions throughout Europe and the US. NonStop is committed to connecting talented individuals like you with exciting opportunities, assisting clients in securing the best talent for their teams. For further details about this role and others, please visit the NonStop Consulting website for more information and available positions.