Junior Regulatory Affairs Officer Job – at Ipsen, Apply Now!
Kickstart your career in regulatory and quality affairs with Ipsen – a global biopharmaceutical leader! We’re hiring a Junior Regulatory & Quality Officer in Hoofddorp, Netherlands to support regulatory submissions, quality compliance, and product lifecycle management across the Benelux region. If you’re a life sciences graduate with 2+ years of experience in pharma regulatory affairs or quality assurance, and fluent in Dutch and English, this is your chance to grow with a company making a meaningful impact in oncology, rare diseases, and neuroscience. Join Ipsen and help bring transformative medicines to patients worldwide.
- Job Posting: Junior Regulatory Affairs Officer
- Locations: Hoofddorp
- Job Requisition ID: R-19325
- Department: Regulatory & Quality Affairs
About The Company
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease, and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France, and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence, and impact. At Ipsen, every individual is empowered to be their true selves, grow, and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
Role Overview
As a Junior Regulatory & Quality Officer, you will play a pivotal role in maintaining compliance with regulatory frameworks and ensuring product quality across Belgium, Luxembourg, and the Netherlands (Benelux). Reporting to the Head of RA & Q BNLX, you’ll support critical activities related to product life cycle management, local SOPs, audits, and pharmacovigilance.
Key Responsibilities
Regulatory Affairs
- Prepare and manage marketing authorizations, renewals, and variations.
- Review and translate SmPCs, PILs, and labelling materials.
- Support packaging material updates and stakeholder coordination.
- Maintain regulatory databases and ensure compliant product listings.
Quality Assurance
- Handle workflows for complaints, deviations, CAPAs, and audits.
- Act as Deputy Quality Contact and support the Responsible Person.
- Maintain inspection readiness and support pharmacovigilance and transparency reporting.
- Ensure compliance with local SOPs and GDP/GMP guidelines.
Ideal Candidate Profile
- Degree in Pharmacy, Biology, Biochemistry, or a related life science field.
- 2+ years of experience in Regulatory Affairs and/or Quality in pharma or healthcare.
- Strong working knowledge of GDP/GMP and European regulatory frameworks.
- Fluent in Dutch and English; French is an advantage.
- Meticulous, proactive, and organized with a problem-solving mindset.
Why Join Ipsen?
At Ipsen, we put patients and people first. Joining our Benelux Regulatory & Quality team means:
- A fast-paced, high-impact environment in a Great Place to Work-certified company.
- The opportunity to grow from Junior to Senior Officer with expert mentorship.
- Contributing to breakthrough therapies in oncology, rare diseases, and neuroscience.
- Being part of a team that values ethics, collaboration, and diversity
Keywords: Junior Regulatory Affairs Officer, Hoofddorp, Ipsen, Job Opportunity, Regulatory Affairs, Quality Officer
