Regulatory Affairs Officer

About HUB:

Hubrecht Organoid Technology (HUB) is a fast-growing biotech company, founded on the pioneering work of Prof. Dr. Hans Clevers who discovered methods to grow stem cell-derived human epithelial “mini-organs” (organoids) from tissues of patients with various diseases including cancer and cystic fibrosis. HUB builds comprehensive Living Biobanks of well-characterized organoids and develops assays for drug screening and validation. The organoid technology enables predictive diagnostics and clinical trial patient stratification.

We are currently seeking a highly motivated RA Officer.

 

Scope of position:

As RA Officer at HUB you work closely together with the RA Manager. You build and maintain solid working relationships with both internal HUB departments as well as external stakeholders such as the Ethical Committee (EC) and hospitals.
You will liaise with a team of top researchers in the field of adult stem cells and contribute to the optimization and innovation of a world leader biotech company on Organoid Technology that has already disrupted human health, providing patients access to novel treatments.
As RA Assistant you are key to our results!
Your activities include, but are not limited to,
• Editing release protocols for our worldwide, academic partners;
• Ensuring a smooth submission and follow up of release protocols and MTA’s (Material Transfer Agreements) with the Ethical Committee according to Biobank Regulations;
• First point of contact for EC queries:
• 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;
• Implementing Biobank protocols including logistics in various hospitals in the Netherlands;
• Registering status updates on protocols and submissions in internal databases.

Qualifications:

Suitable candidates meet the following requirements;
• Master degree (or Bachelor + 4 years ) with a minimum of 2 years of related work experience in the field of Life Science & Technology, Biomedical Science or a related field or an equivalent combination of education and experience,
• Work experience in a pharmaceutical or biotech company is strongly preferred,
• In Vitro Diagnostics Regulation is a strong pre;
• Ability to work with tight deadlines and running several projects in parallel adjusting priorities appropriately,
• Proficiency in English and Dutch (verbal and written),
• Ability to understand medical terminology,
• Excellent communication and interpersonal skills,
• Capability to perform RA activities strictly according to Standard Operating Procedures (SOP) and therefore mastering a high degree of accuracy,
• Availability of minimum 32 hours per week

What we offer:

A high paced, professional and international environment.

A positive and energetic team allowing you to make a difference.

Opportunity to grow in this position alongside HUB’s development.

Interested?

We look forward to receiving your cover letter and resume, in English. Please send them to Arianne Piesaar-Aalbers, HR Manager (a.aalbers@hub4organoids.nl).

January 15, 2020 Patent Attorney About HUB: Hubrecht Organoid Technology (HUB) is a fast-growing biotech company, founded on the pioneering work of Prof.... read more
January 15, 2020 Bedrijfsjurist Over HUB: Stichting Hubrecht Organoid Technology (HUB) is een snelgroeiend biotechbedrijf dat een platform van organoïd... read more
December 19, 2019 Scientist Immunology About HUB: Hubrecht Organoid Technology (HUB) is a fast-growing biotech company, founded on the pioneering work of Prof.... read more