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Regulatory Affairs Consultant Pharmaceuticals [F/M/X]

Bruxeles
Permanent Job
English, Dutch

Job description

Job description

As a Regulatory Affairs Consultant in the pharmaceutical industry, you will play a key role in ensuring compliance of products and processes with applicable regulations and standards. You will be part of Amaris’ Life Sciences team, supporting major clients in the Netherlands in their regulatory submissions, documentation, and interactions with health authorities.


Your missions

  • Prepare and review regulatory documentation for product registration and maintenance.

  • Support regulatory submissions in compliance with EMA and local Dutch authorities.

  • Coordinate with cross-functional teams (Quality Assurance, R&D, Clinical, Manufacturing).

  • Monitor regulatory changes and assess their impact on current and future products.

  • Ensure compliance throughout the product life cycle, from development to post-marketing.

  • Provide guidance on local and European regulatory requirements.


Your profile

  • You hold a Master’s degree or PhD in Life Sciences, Pharmacy, or a related field.

  • 2–5 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.

  • Familiarity with EMA procedures, variation submissions, and marketing authorization maintenance.

  • Fluent in Dutch and English (both written and spoken).

  • Excellent organizational, communication, and teamwork skills.

  • Curious, detail-oriented, and eager to grow in an international consulting environment.


What we offer

  • A dynamic and international environment where you can work with top-tier pharmaceutical clients.

  • Continuous training through the Amaris Academy, offering access to hundreds of development programs and certifications.

  • Personalized career paths to help you progress vertically or broaden your expertise across Life Sciences domains.

  • A hybrid work model combining office and home working for flexibility.

  • A culture of meritocracy, inclusion, and entrepreneurship—your ideas matter.


At Amaris Consulting, we believe diversity is a strength. We are committed to creating an inclusive workplace that promotes equality of opportunity, respects differences, and values each individual’s contribution. We encourage applications from all qualified candidates regardless of gender, background, or identity.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:   

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you! 

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.   

As you know, every person is different and so is every role in a company.  That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. 
We look forward to meeting you!

Interested in this job?

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