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Regulatory Manager
1 maand geleden
Join our dynamic team at Julius Clinical as a Regulatory & Start-up Lead , where your expertise in regulatory legislation and exceptional communication skills will play a pivotal role in managing global clinical trials.
As a Regulatory & Start-up Lead, you'll take ownership of the clinical trial applications (Phase I-IV) to the applicable reviewing bodies (e.g. via CTIS, IRAS), working alongside our driven Regulatory team to ensure the highest standards of quality and compliance. Reporting directly to our Senior Manager Regulatory, you'll be responsible for:
- Acting as a liaison between the client, the project team, our local partners, vendors, review committees, and regulatory agencies to ensure protocol approval and timely provision of supplementary information.
- Creating a comprehensive submissions and approval plan at the project outset.
- Ensuring a high level of quality of the clinical trial submission processes by performing Quality Control activities.
- Ensuring all local activities adhere to agreed timelines, allocated budgets, and required quality standards.
- Reporting progress to stakeholders and identifying/assessing regulatory risks and project issues.
- Ensuring compliance of regulatory processes with national and international laws and regulations.
- Providing input to proposals and bid defences on regulatory and ethics submissions activities.
To excel in this role, you'll need:
- Higher education degree, preferably in pharmacy or life sciences.
- Approximately 5 years of experience in Clinical Trials, with 2-3 years specifically within the Regulatory field/submissions.
- Extensive knowledge of EU Clinical Trial Regulation, ICH guidelines, and international submission regulations.
- Familiarity with Medical Devices regulations (preferable).
- Proficiency in written and spoken English and preferably in Dutch, with French language skills considered advantageous.
- Strong communication, multitasking, leadership, and stress-resistant abilities.
In return, we offer an open and innovative work culture, inspiring colleagues, and excellent working conditions. You'll have the freedom to be creative, take initiative, and directly influence our operations. Our office is conveniently located near Slot Zeist with easy access to public transportation. You'll have the flexibility to combine working from the office with working from home.
Interested?
If you're excited about this opportunity, please send your CV and motivation to vacancies@juliusclinical.com. Join us in making a difference in the field of clinical research
Questions?
If you have any further questions, please contact Ellen Hunink (HR Business Partner, +31 6 2116 2980) or Niki de Vink (Senior Manager Regulatory).
