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Program Manager Regulatory Innovation

17 NOV '23: For Oncode Accelerator, a national growth fund program that aims to innovate the preclinical development process for cancer therapy, we are currently looking for a Program Manager Regulatory Innovation. If you think that drugs can be developed faster and less expensively, and that the patient should be at the center of development, please continue reading.

Details

Biotechnical

Quality/RA

Utrecht - Netherlands

40 hours per week

Get to know

Your consultant

Martin van der Velden

+31 6 82 05 77 09 m.vandervelden@qtcrecruitment.com

About your role

This is how you will make the difference

As Program Manager Regulatory Innovation, you will be instrumental in aligning with regulatory authorities to ensure that Oncode Accelerator's innovative methodologies are adopted and implemented for the validation of new therapies. These methodologies stem from the innovation platforms: Well-Defined Patient Cohorts, Organoid Models and Artificial Intelligence. These will enable better prediction of the safety and efficacy of new therapies for specific patient populations. You will operate within The Regulatory Innovation workstream which will conduct regulatory studies on the Oncode Accelerator innovation platforms, assess their impact and readiness, and establish interactive tools for the dissemination of regulatory information.

what's needed

What you bring

You, as a Regulatory professional, will recognise yourself in the following. You have:

3+ years of professional experience (or a Ph.D.) in a relevant field, preferably in regulatory science, medical technology or health policy;
Familiarity with preclinical drug discovery & development and pharmaceutical clinical trials;
Knowledge of regulatory policies and procedures for obtaining marketing authorisation;
Preferably, but not necessarily, a good understanding of the Dutch healthcare system, for example through one or more years of professional experience in a relevant organisation;
Excellent organisational, planning, and execution skills, preferably with experience in using project management tools;
Structured, results-oriented, punctual with a desire to excel in operational quality;
Strong work ethic with the ability to work both independently and as part of a team;
Proactive and flexible, not afraid to “jump in” when needed;
Excellent interpersonal communication skills, with a command of the Dutch language.

What we offer

What's in it for you

Making sure the innovative initiatives that are being developed will be adopted and implemented is the challenge at hand. The reward is a disruption in preclinical development as we know it. Besides that, the organisation offers:

A competitive salary;
30 vacation days per year (based on full-time employment);
Good secondary working conditions.

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This is how you will make the difference

What you bring

What's in it for you

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