Regulatory Compliance Manager

2 weken geleden


Utrecht, Utrecht, Nederland Julius Clinical Voltijd
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.
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.
Ensuring compliance of regulatory processes with national and international laws and regulations.
To excel in this role, you'll need:
Familiarity with Medical Devices regulations (preferable).
Proficiency in written and spoken English and preferably in Dutch, with French language skills considered advantageous.
You'll have the freedom to be creative, take initiative, and directly influence our operations. You'll have the flexibility to combine working from the office with working from home.

If you have any further questions, please contact Ellen Hunink (HR Business Partner, +31 6 2116 2980) or Niki de Vink (Senior Manager Regulatory).
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