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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs with a focus on marketing authorization applications, product registrations, and compliance with local regulatory requirements. Proficient in managing regulatory documentation and lifecycle activities while ensuring data accuracy and adherence to submission timelines.
Highest-signal resume keywords
Regulatory Affairs ExperienceMarketing Authorization Lifecycle ManagementRegulatory SubmissionsFluency in English and FrenchExperience with Vault RIM
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsMarketing Authorization ApplicationsProduct RegistrationsRegulatory ComplianceLabelling ActivitiesXEVMPD UpdatesClinical Trial LabellingCompassionate Use ProgramsMedical Device RegulationsAttention to Detail
Soft Skills
Strong Organizational SkillsAbility to Manage Multiple PrioritiesAutonomous Work Capability
Tools & Technologies
Vault RIMXEVMPDLIFTTVT
Industry Keywords
Pharmaceutical IndustryBelgian Regulatory RequirementsLuxembourg Regulatory RequirementsRegulatory DocumentationQuality Compliance
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Prepare, submit, and track marketing authorization applications, variations, and renewals.
- Manage product registrations and lifecycle activities within Vault RIM.
- Maintain regulatory databases, including XEVMPD updates, ensuring data accuracy and compliance.
- Coordinate, maintain, and archive regulatory documentation.
- Ensure compliance with local regulatory requirements and submission timelines.
- Coordinate and review regulatory labelling documents, including SmPCs, package leaflets, and product labels, and manage translations in Dutch, French, and German.
- Support labelling change requests, artwork reviews, approvals, and submission mock-ups.
- Support clinical trial labelling activities, including review of labels, Directions for Use, and translated materials.
- Provide regulatory support for medical devices, including product registrations, documentation maintenance, IFU translations, and labelling compliance.
- Contribute to Compassionate Use and Medical Need Programs, regulatory intelligence activities, and quality/compliance support.
Requirements
What you’ll need- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, or a related field.
- Previous Regulatory Affairs experience within the pharmaceutical industry.
- Good knowledge of Belgian and Luxembourg regulatory requirements.
- Hands-on experience with regulatory submissions, marketing authorization lifecycle management, and/or labelling activities.
- Ability to work autonomously and provide operational support with minimal onboarding.
- Strong organizational skills, attention to detail, and ability to manage multiple priorities.
- Experience with regulatory tools such as Vault RIM, XEVMPD, LIFT, and/or TVT is a strong asset.
- Knowledge of medical device regulations and clinical trial labelling is desirable.
- Experience with Compassionate Use and Medical Need Programs is a plus.
- Fluency in English and preferably French and/or Dutch; German is considered an advantage.
Benefits
Comp & perks- Opportunity to work with Excelya, a healthcare company and mid-size CRO
- Diverse projects through full-service, functional service provider, and consulting offerings
- Working alongside preeminent experts
- Environment valuing natural talents, professional growth, and individual development
- Inclusive, collaborative workplace
- Best employee experience focus