Regulatory Affairs Officer

airliquidehr; Zaventem; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

Air Liquide Medical Ltd. NV is seeking a Regulatory Affairs Specialist in Zaventem. Your role includes managing submissions of Marketing Authorization Applications and ensuring compliance with medical device regulations. You'll monitor progress with authorities and communicate decisions effectively.

The ideal candidate has 3-5 years of experience in a pharmaceutical environment, is a good communicator, and is fluent in French, Dutch, and English. Join us in our mission to support healthcare professionals and patients effectively.

Qualifications

• 3-5 years professional experience in regulatory affairs in a pharmaceutical environment.
• Ability to work under stress and remain steadfast in challenging situations.
• Strong accuracy and organizational skills.

Responsabilités

• Submit new Marketing Authorization Applications (MA’s) to the relevant authorities.
• Collaborate with corporate for European procedures on MA’s.
• Monitor progress and communicate decisions to stakeholders.

Connaissances

Pharmaceutical regulatory experience

Team player

Good communication skills

Analytical skills

Multi-language (French, Dutch, English)

Description du poste

Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives. We are constantly inventing and developing solutions for healthcare facilities. In the Hospital Care (Belux) business, our employees serve more than 7,500 hospitals and clinics every day, supplying them with oxygen and other medical gases. In the Homecare business (Belux), our employees take care of the respiratory treatment at home of, among others, more than 40,000 patients.

How will you CONTRIBUTE and GROW?

You are in charge of various assignments related to pharmaceutical regulatory affairs, including the submission of new Marketing Authorization Applications and variations of the existing MA’s, as well as updating leaflets, SmPCs and labeling for each medicine. You perform these tasks, monitor their progress with the relevant Belgian, Dutch, or Luxembourgish authorities, and communicate their decisions to the relevant stakeholders. You are responsible for registering and checking requests for sponsorship and promotional material under the supervision of the Responsible for Information and Publicity (RIP), who gives final approval on each file and for whom you act as a backup. You also play a role in ensuring compliance with MDR requirements by collecting all quality‑related data for the medical devices we distribute and by participating in supplier assessments.

• Submission of new Marketing Authorization Applications (MA’s) to the FAMHP, the MEB, or the Ministry of Luxemburg.
• Submission of variations to existing MA’s to the FAMHP, the MEB, or the Ministry of Luxemburg.
• Collaboration with Air Liquide Santé International (Corporate) within the framework of European procedures (DCP or MRP).
• Provision of updated SmPCs to the sales teams.
• Check and approval of mock‑ups (digital version) for labels and leaflets in the Benelux region.
• Registration, checking and monitoring of sponsorship applications for the Benelux.
• Submission of Mdeon (Belgium) and ‘preventieve toetsing’ (Netherlands) visa applications.
• Preparation of files relating to the publication of transfers of value.
• Registering, checking and monitoring requests for validation of promotional material for the Benelux.
• Involvement in product creation (in our traceability system) by gathering quality documentation from new medical devices we distribute.
• Contribution to supplier assessments by collecting quality data from new medical device suppliers.

Are you a MATCH?

• 3-5 years professional experience in regulatory affairs in a pharmaceutical environment.
• Team player, stress resistant, and steadfast.
• Good communication and social skills.
• Accuracy and structuring qualities.
• Acts according to plan and sets priorities, makes efficient use of methods, systems and resources.
• Analytical, helicopter view, flexible.
• Open personality, pragmatic.
• French, Dutch and English speaking.

Our Differences make our Performance

At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.