Regulatory Affairs Officer

pJoin Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. /ppWe are looking for an experienced Regulatory Affairs Officer to provide temporary, part-time operational support for regulatory activities (BeLux). /ppThe consultant will support the local Regulatory Affairs team with regulatory submissions, marketing authorisation lifecycle management, labelling activities, and regulatory compliance for pharmaceutical products and medical devices. /ph3Key

Responsibilities:
/h3ullipPrepare, submit, and track marketing authorization applications, variations, and renewals. /p /lilipManage product registrations and lifecycle activities within Vault RIM. /p /lilipMaintain regulatory databases, including XEVMPD updates, ensuring data accuracy and compliance. /p /lilipCoordinate, maintain, and archive regulatory documentation. /p /lilipEnsure compliance with local regulatory requirements and submission timelines. /p /lilipCoordinate and review regulatory labelling documents (SmPCs, package leaflets, and product labels) and manage translations in Dutch, French, and German. /p /lilipSupport labelling change requests, artwork reviews, approvals, and submission mock-ups. /p /lilipSupport clinical trial labelling activities, including review of labels, Directions for Use (DFUs), and translated materials. /p /lilipProvide regulatory support for medical devices, including product registrations, documentation maintenance, IFU translations, and labelling compliance. /p /lilipContribute to Compassionate Use and Medical Need Programs, regulatory intelligence activities, and quality/compliance support. /p /lilipBachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Sciences, or a related field. /p /lilipPrevious Regulatory Affairs experience within the pharmaceutical industry. /p /lilipGood knowledge of Belgian and Luxembourg regulatory requirements. /p /lilipHands-on experience with regulatory submissions, marketing authorization lifecycle management, and/or labelling activities. /p /lilipAbility to work autonomously and provide operational support with minimal onboarding. /p /lilipStrong organizational skills, attention to detail, and ability to manage multiple priorities. /p /lilipExperience with regulatory tools such as Vault RIM, XEVMPD, LIFT, and/or TVT is a strong asset. /p /lilipKnowledge of medical device regulations and clinical trial labelling is desirable. /p /lilipExperience with Compassionate Use and Medical Need Programs is a plus. /p /lilipFluency in English and preferably French and/or Dutch; German is considered an advantage. /p /li /ulh3Why Join Us? /h3pAt Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. /ph3Here’s what makes us unique. /h3pWe are a young, ambitious health company representing 900 Excelyates, driven to become Europe’sleading mid-size CROwith thebest employee experience. Ourone-stop provider service modeloffering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey. /ppExcelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission. /p