Regulatory Affairs Manager/Senior Associate

☞ Pfizer

전망: 135

갱신일: 06-12-2025

위치: Elsene Brussels Capital

범주: 마케팅 / 홍보

산업:

직업 종류: Full-time

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작업 내용

Do you want to be part of an international, innovative, world-class pharmaceutical company? Of an organization 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.
Interested to join our dynamic Pfizer’s Regulatory Affairs Belux Team that is passionate about bringing breakthrough medicines to the Belgian and Luxemburg patient? Then check this job opening within our team!
Location: Brussels.
About the role
The purpose of this position is to allow Pfizer to legally study, manufacture, market and supply medicines by obtaining, managing and maintaining product Marketing Authorizations in line with business goals and legal requirements.
The key accountabilities of the Regulatory Affairs Manager/Senior associate are:
  • To conduct associated regulatory activities for the Belgium and Luxembourg market in full compliance with national, regional and global regulatory requirements and internal standards and procedures, under minimal supervision.
  • To contribute to the implementation and leading of national/regional/global projects within regulatory, as well as cross-functionally and cross-divisionally and building of expertise within the Regulatory Department, Global Regulatory Sciences and Global Product Development, striving for continuous improvement of regulatory processes.
Main responsibilities
  • Attend relevant product team meetings with cross-divisional colleagues to provide regulatory guidance and support as necessary. Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
  • Provide regulatory feedback and insights of regulatory milestones before, during and after Marketing Authorisation Application Procedure to cross-functional team members and ensure that all regulatory actions are executed in time for launch.
  • In partnership with above-country operational hubs, above-country strategists, and local clinical operations or third party vendors, give support to prepare the agreed Clinical Trial Application (CTA) submission documentation for initial application and subsequent amendments/modifications, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority (RA) queries.
  • Work with regional strategists to provide country input into Global and European Regulatory Strategies as required (e.g. labelling discussion prior to submission).
About you
  • Life sciences or chemistry graduate to honours level or equivalent through work experience. Masters Degree, Post Graduate Diploma or PhD preferred.
  • Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products). Strong knowledge of the Belux and European environment, rules, regulations and procedures, and how this impacts regulatory strategy and implementation.
  • Dutch (C1), French (C1) & English (C1). German knowledge is an asset (B1).
  • Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
  • Team player, analytical thinker, quality and compliance oriented
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?
Do you know enough and have you decided to respond? We are curious about you and invite you to submit your application via the apply button below. You don’t have to worry about a deadline to respond. We keep looking until we have found the right candidate for this position.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
We kindly ask you to provide your application documents in English!
#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) Elsene , the Belgian headquarters, 3) Puurs , Pfizer’s production and packaging site, and 4) Zaventem, the international Pfizer’s Logistics Center.
More information can be found at
www.pfizer.com
,
www.pfizer.be
and on Facebook and Twitter.
Regulatory Affairs
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마감 시간: 20-01-2026

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