Quality & Regulatory Officer Benelux (temp. 6m)

at  Ipsen NV

Are you passionate about ensuring top-notch quality and compliance in the pharmaceutical industry? Do you thrive in a dynamic and collaborative environment? If so, we have an exciting opportunity for you!
Due to pregnancy leave we are looking for a temporarily Senior RQ Officer to join our team at Ipsen Benelux. In this role, you will actively ensure the quality assurance function within our organization. You will oversee the maintenance of product quality and compliance through Quality Assurance and Quality Control functions, as well as manage the Quality Management System and its processes.
As a Senior RQ Officer, you will take the lead on the assigned Specialty Care portfolio, preparing, submitting, and following up on dossiers for marketing authorization applications, variations, renewals, and responses to questions from authorities in Benelux. You will collaborate with Global Regulatory Affairs to develop accurate translations of SmPC, PIL, and labeling within the portfolio. Additionally, you will ensure timely submission, review, and follow-up of packaging materials, update product information on internal and external platforms, and inform third parties in line with regulatory and Ipsen requirements.
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences and rare diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

EXPERIENCE / QUALIFICATIONS

• Experience in pharma or pharmacy setting.
• 4 years of experience within Regulatory Affairs, and Quality, in a matrix environment.
• Proven track of GDP/GMP knowledge, and the drive to achieve. GDP trained.
• Fluent, both written/spoken, in Dutch, French, and English are essential to the function.
• Pharmacist preferred.
• Experience in Belgium and NL preferred

PURPOSE OF THE POSITION

The Senior Regulatory & Quality Officer actively delivers on Regulatory requirements for Ipsen Benelux ensuring smooth launch readiness, product continuity & compliance for the relevant territories: Belgium, Luxembourg, the Netherlands.
She / he actively ensures the Quality assurance function within Ipsen Benelux.
She / he oversees the maintenance of product quality & compliance through the Quality Assurance & Quality Control functions, as well as management of the Quality Management System and its processes.