Qualified Person with regulatory affairs expertise.
Explore the role, responsibilities, and expectations to see
if this position fits your experience and ambitions.
- QP / RP
- Operations
- EU Importation
- Inspection
- Transtion
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Our culture is driven by excellence and responsibility. We operate with integrity, place our customers at the center of our decisions, and value collaboration, anticipation, and pragmatism. A holistic view allows us to deliver consistent quality and long-term value.
We are seeking an experienced and detail-oriented Regulatory Affairs & Qualified Person (QP) Specialist to join our growing team. In this pivotal and versatile role, you will have a dual mission:
- Internal Expert: Managing end-to-end eCTD submissions and acting as the Qualified Person for our product portfolio.
- External Consultant: Providing expert regulatory and QP consultancy services to our clients. You will assess their needs, develop strategies, and directly support them with dossier submissions, change management, and compliance projects, executing missions either remotely or on-site at their facilities.
This role offers a unique blend of in-house responsibility and external client engagement.
If you are not already a registered Qualified Person in Belgium, we are committed to supporting you through the necessary training and experience to obtain the official certification and approval from the Belgian Federal Agency for Medicines and Health Products (FAMHP).
Essential Job Functions (Qualified Person):
- Is eligible to act as a European Qualified Person, certifying products in accordance with Directives 2001/83/EC, 2003/94, Regulation (EU) No 536/2014 and Annex 16, with relevant experience in sterile and solid dosage form manufacture and testing.
- Executes drug product batch certification and release functions in accordance with Directives 2001/83/EC, 2003/94, Annex 16, Annex 21, commercial tenders, or special supply requirements.
- Assists in preparing for, hosting, and responding to commitments associated with regulatory and internal inspections; executes internal and external audits as required.
- Manages partners or vendors as required.
- Maintains Continuous Professional Development (CPD) in conformance with professional body expectations and contributes to site training programs, as required.
Essential Job Functions (Regulatory Affairs):
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Regulatory Dossier Preparation & Submission:
Prepare, compile, review, and publish high-quality eCTD submissions for CTAs, MAAs, renewals, and routine reports in accordance with ICH, EMA, and national requirements.
Manage publishing tasks including document rendering, bookmarking, hyperlinking, and validation using specialized software (e.g., Extedo eCTDManager, ISI Toolbox).
Perform rigorous quality control checks to ensure legibility, completeness, and accuracy prior to submission.
Take a lead role in preparing and managing full application submission builds. -
Change Control Assessment & Submission:
Conduct comprehensive assessments of proposed CMC and other changes to determine appropriate regulatory classification and submission strategy across European markets.
Develop and execute regulatory strategies for Variations, Extensions, and Notifications in line with EU guidelines.
Prepare and submit all documentation required for post-approval changes, including updated Module 3 and Module 1 documents.
Coordinate with cross-functional teams to collect data and align on implementation timelines. -
Portal Management & Submission Expertise:
Act as the primary point of contact for electronic submissions via the Common European Submission Portal (CESP).
Manage submissions to the Belgian Federal Agency for Medicines and Health Products (FAMHP) and other authorities in compliance with national technical requirements.
Ensure adherence to linguistic requirements for national and European procedures.
Troubleshoot technical issues related to eCTD builds and portal submissions. -
Cross-Functional Collaboration & Compliance:
Provide regulatory guidance to project teams throughout development and lifecycle management.
Maintain up-to-date knowledge of EU and national regulatory guidelines and proactively monitor regulatory changes.
Maintain structured regulatory archives and track the status of all submissions.
Experience & Education:
- Bachelor’s or master’s degree in Life Sciences, Pharmacy, or a related field.
- Minimum of 3–5 years of direct regulatory affairs experience within the pharmaceutical industry, with a focus on EU procedures.
Technical Skills & Knowledge:
- Proven, hands-on experience in preparing and publishing eCTD submissions for the EU market (CTAs, MAAs, Variations).
- In-depth, practical knowledge of key EU submission portals, including CESP and the Belgian FAMHP national system.
- Proficiency with industry-standard publishing software (e.g., Extedo eCTDManager, ISI Toolbox).
- Solid understanding of the EU regulatory framework, including the Notice to Applicants (NtA) and MRP procedures.
- Familiarity with Belgian national regulatory requirements and the role of the FAMHP is a significant advantage.
- Professional proficiency in English is required; fluency in Dutch and/or French is highly preferred.
Personal Attributes:
- Exceptional attention to detail and accuracy.
- Strong organizational skills with the ability to prioritize and manage multiple complex projects under tight deadlines.
- Excellent problem-solving and analytical abilities.
- Effective communication skills, with the ability to liaise clearly with health authorities and internal cross-functional teams.
- Proactive, self-motivated, and a collaborative team player.
We provide a dynamic and rewarding career that blends impactful work with personal growth and flexibility.
- A key and versatile role in a science-driven company with a promising pipeline, where you can take ownership of critical regulatory and quality processes.
- A supportive, collaborative, and international work environment built on expertise and shared success.
- Direct pathways for professional growth through diverse projects—from internal pipeline work to external consultancy missions with our global customer network.
- Access to targeted training and a dedicated network of internal and external experts to continuously advance your skills.
- A modern, hybrid work model that offers flexibility to work remotely, from our offices, or on-site with customers based on project needs.
- A competitive salary and a comprehensive benefits package.
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