Regulatory Associate

Do you want to be part of an international, innovative, world-class pharmaceutical company committed to putting patients first. Pfizer has always evolved with the changing needs of the people who rely on us to create a healthier world. Guided by our four values: Courage, Joy, Equity and Excellence, our breakthrough culture lends itself to our dedication to transforming millions of lives.

Location: Pfizer Clinical Research Unit Belgium

About the role

The Regulatory Associate provides logístical and administrative support to the Regulatory Department. This includes contributing to the preparation, processing, and electronic archiving of all regulatory submissions and global initiatives.

Main responsibilities
- Provide support to ensure timely and accurate Institutional Review Board submissions so that studies are conducted scientifically and ethically in compliance with Food & Drug Administration, International Conference on Harmonization and Good Clinical Practice guidance/ regulation.
- Ensure that all local and global systems, tracking tools and databases are continuously and accurately updated with regulatory information.
- Develop processes for and coordinate routine quality checking of regulatory databases and systems
- In compliance with applicable local and corporate standard operating principles and best practices, manage and complete all regulatory system requirements in collaboration with Regulatory Affairs colleagues, by checking events and regulatory and submissions-related activities
- Provide the administrative work related to completion of trials including the associated communications to the Institutional Review Board
- Manages the maintenance and archiving of study files.

About you
- Bachelor’s degree in management/(Medical) Secretarial Assistant, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
- 5+ years of experience in the field of administration, secretarial work or office management, of which at least some years in a regulatory environment
- Proficient in Outlook, Word, Excel and PowerPoint.
- English (C1)

What do we offer?

Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions. As a Pfizer colleague, you'll have the opportunity to maximize the impact of medicines for patients in a variety of ways. In short, you make a real difference.

Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Dutch organization. There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.

A culture where you can be yourself We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that's what we strive for and live by.

Work/life balance At Pfizer, we know that if you really want to make an impact on people's lives, it's important that your people are at their best. That's why we offer our colleagues good working conditions, such as an appropriate salary and opportunities to work from home. Working a lot of overtime is not the norm for us. We also believe that work and having fun should go hand in hand. That's why, for example, you can participate in all kinds of activities outside of work.

Are you interested?

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

LI-PFE
- Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story._
- Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2)_
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- Elsene_
- , the Belgian headquarters, 3)_
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- Puurs_
- , Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center._
- More information can be found at_
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- and on Facebook and Twitter._

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