Regulatory Affairs Pharma [F/M/X]

Job description

Role Overview

The Regulatory Affairs Specialist is responsible for providing procedural, administrative, and planning support for new submissions and variation submissions in the EU, UK, Switzerland, and non‑EU Balkan countries for products approved through centralized and decentralized/MRP procedures.

You will work closely with Country Regulatory Affairs teams and Regulatory Operations to ensure high‑quality, timely submissions in line with EU regulatory requirements.

Key Responsibilities

Provide administrative regulatory support during the filing and review of new submissions and variations to ensure compliance with EU requirements.

Plan and coordinate new submissions, variations, CHMP referrals, and FUM to ensure timely submission.

Draft Module 1 components and coordinate the collection and organization of all Module 1 documentation.

Collaborate closely with Regulatory Operations to define submission timelines and Module 1 content.

Work in close partnership with Country RA Registration Managers to secure timely submissions in all relevant markets.

For centralized procedures, supervise and coordinate the translation process to ensure on‑time submission to EMA.

Provide additional administrative support related to Marketing Authorization Applications to senior Regulatory Affairs staff (Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist, Senior Scientist) as needed.

Ensure accurate and timely updates to regulatory databases and tracking tools.

Stay current with EU procedural requirements, guidelines, and legislation, and apply them in daily activities.

Participate as Subject Matter Expert (SME) in relevant workstreams and projects as assigned by Regulatory Affairs Europe senior leadership.

Candidate Profile

Must‑Have Qualifications

University degree (or equivalent, e.g., A1 in Belgium), preferably in a scientific discipline related to medicine (e.g., Pharmacy, Life Sciences, Medicine, Biology, Chemistry).

4–6 years of experience in the pharmaceutical industry, with solid knowledge of the drug development and/or approval process.

Proven experience in EU regulatory submissions (centralized and/or decentralized/MRP) and lifecycle management is a strong asset.

Good command of English (written and spoken).

Skills \& Competencies

Strong organizational skills and proven ability to manage multiple tasks and deadlines simultaneously.

Excellent written and verbal communication skills in English.

Ability to work effectively across functions, cultures, and geographical boundaries; acts as an intermediary between stakeholders.

Demonstrated ability to evaluate new ideas and proposed methods for practicality and ease of implementation.

Strong coordination skills: able to align tasks with others to ensure timely completion and avoid setbacks.

High attention to detail with the ability to review regulatory documents for accuracy and identify potential errors.

Solid understanding of the end‑to‑end pharmaceutical product lifecycle.

Ability to consider recent innovations and regulatory trends when formulating recommendations.

Experience in evaluating activities and business processes across functions, identifying areas for improvement, and contributing to or leading solution design and implementation.

Applies and advises on company policies, procedures, and applicable regulations and standards (e.g., EU guidelines, EMA requirements).

Why joining us?

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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!

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