Scope of position

We are a diverse team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.

As a Regulatory affairs officer you provide regulatory support for Organoid Technology projects as well as biobank related activities under supervision of RA Manager. You will:

  • Provide regulatory support and information to projects
  • Supports the business in its core activities by complying to regulations and ethical processes
  • Take lead on creating awareness in organization on regulatory requirements
  • Work closely with internal and external stakeholders such as Ethical Committee and hospitals
  • Review project regulatory documentation to ensure compliance with applicable regulatory laws, regulations and guidelines.

You work closely with our technology transfer staff, Chief Scientific Officer (CSO), and research teams to manage regulatory related requirements and compliance. As Regulatory Affairs Officer, you contribute to the development and implementation of regulatory regulations, guidelines and procedures, working together with your direct manager as well as aforementioned internal and external stakeholders.

Reports to: RA Manager

Your responsibilities and activities include, but are not limited to;

  • Supporting the RA Manager in the identification and interpretation of regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Provides regulatory assessments for assigned research projects – domestic and international under supervision of your reporting Manager
  • Drafting and editing release protocols (similar to research plan) for worldwide clients and academic partners
  • Ensuring a smooth submission and follow up of release protocols and MTA’s (Material Transfer Agreements) with the Ethics Committee according to biobank regulations
  • Coordinating HUB Biobanks:
  • Prepare/write biobank protocols and amendments for ethical committee
  • Initiate and contact hospitals for the sourcing of new samples (together with Legal)
  • Drafting, proofreading and submitting biobank protocols as well as Patient Information Sheets (PIF) and Informed Consent Forms (ICF) with the EC, in line with the Biobank Regulations
  • Serving as a first point of contact for ethical committees
  • Implementing Biobank protocols including logistics in various hospitals in the Netherlands
  • Registering status updates on customers, protocols and submissions in HUB’s internal databases
  • Capability to perform RA activities strictly according to standard operating procedures
  • Develop company regulatory policies and ensures harmonization with relevant regulations, quality standards and GxP (e.g. GDPR, IVDR, ISO13485).

Skills

  • Work experience in areas relevant to regulatory affairs and clinical research. Work experience in a pharmaceutical or biotech company preferred.
  • Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies. Knowledge of the In Vitro Diagnostics Regulation is a plus.
  • Must be able to independently coordinate with interdisciplinary team members, manage timelines and compile documents for ethical committee submissions
  • Ability to understand medical terminology
  • Ability to work on several projects, retaining quality and timelines and can prioritise workload under the supervision of reporting manager
  • Ability to propose revisions to SOPs or suggest process improvements for consideration
  • Proficiency in English (verbal and written), Knowledge of Dutch is a plus
  • Excellent communication and interpersonal skills
  • High degree of accuracy

Qualifications

  • Master’s degree with a minimum of 2 years related work experience or Bachelor’s with a minimum of 4 years related work experience.
  • Excellent analytical and communication skills, particularly writing skills.
  • Knowledge of regulatory document processing, document management, or other experience directly relevant to Regulatory Operations
  • 2-5 years of professional experience in pharmaceutical/biotech industries, in vitro diagnostic, project management or regulatory affairs
  • Knowledge and experience with both US and European regulatory submission is a plus

What we offer:

  • Genuinely meaningful work as part of a company with unwavering commitment to apply Organoid Technology globally for the benefit of the patients
  • International work environment in a multi-cultural team.

Interested?

Please send your cover letter and resume, in English before 7th of February 2022. We look forward to hearing from you!

apply now

X

Have any questions?

contact us