Our client, a growing consultancy in the Netherlands, is expanding its team and seeking a motivated individual to take on the role of Team Lead Regulatory Affairs. In this role, you will have exposure to a variety of drug development projects for pharmaceutical and biotech clients, providing a closer connection to innovation and diverse scientific projects.
Benefits:
– Collaboration-focused environment, with support from HR, admin, and sales functions, allowing you to delve deeper into scientific and technical aspects without the usual operational burden.
– Flexibility to work from home with only 2 days per week required in the Breda office, offering a better work-life balance and saving time and money on commuting.
– Joining the starting group in Breda, you will have the opportunity to witness and drive positive changes and growth. As a key player in this expansion, you will have the chance to progress with the company, taking on more responsibility at an accelerated pace.
Responsibilities:
– Oversight of multiple projects simultaneously, providing a high level of diversity in your role and enabling you to contribute to different areas within drug development.
– Managing 4 to 5 consultants, sharing your expertise, and fostering their development while freeing up your time to focus on strategic tasks.
– 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.
– Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
Requirements:
– Master’s degree or PhD in life sciences
– Multiple years of experience in Regulatory Affairs in clinical and early drug development
– Global or international experience
– Proficiency in English is required, German and/or Dutch is 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 your application or interview process? Feel free to share this information as part of your application for any necessary adjustments needed to facilitate the process. This information will not impact the outcome of your interview.
About NonStop: We are NonStop, a prominent provider of staffing solutions across Europe and the US, dedicated to connecting talent with opportunities. Visit our website, NonStop Consulting, for more information on available roles and how we can support you.
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