{"id":2847525,"url":"https://alion.io/job/excelya-regulatory-affairs-officer","title":"Regulatory Affairs Officer","company":{"id":4705,"name":"Excelya","domain":"excelya.com","url":"https://alion.io/company/excelya","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"A","score":94,"open_postings":4,"ghost_share":0,"stale_share":0.25,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"part_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Brussels, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":79000,"max_usd":180000,"period":"year","method":"role_country_seniority_unknown","sample_n":8},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"EU MDR","optional":false}],"status":"live","first_seen_at":"2026-10-19T11:49:37Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-11-03T04:37:06Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Join 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.\nWe are looking for an experienced Regulatory Affairs Officer to provide temporary, part-time operational support for regulatory activities (BeLux).\nThe 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.\nKey Responsibilities:\nPrepare, submit, and track marketing authorization applications, variations, and renewals.\nManage product registrations and lifecycle activities within Vault RIM.\nMaintain regulatory databases, including XEVMPD updates, ensuring data accuracy and compliance.\nCoordinate, maintain, and archive regulatory documentation.\nEnsure compliance with local regulatory requirements and submission timelines.\nCoordinate and review regulatory labelling documents (SmPCs, package leaflets, and product labels) and manage translations in Dutch, French, and German.\nSupport labelling change requests, artwork reviews, approvals, and submission mock-ups.\nSupport clinical trial labelling activities, including review of labels, Directions for Use (DFUs), and translated materials.\nProvide regulatory support for medical devices, including product registrations, documentation maintenance, IFU translations, and labelling compliance.\nContribute to Compassionate Use and Medical Need Programs, regulatory intelligence activities, and quality/compliance support.\nRequirements\nBachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, or a related field.\nPrevious Regulatory Affairs experience within the pharmaceutical industry.\nGood knowledge of Belgian and Luxembourg regulatory requirements.\nHands-on experience with regulatory submissions, marketing authorization lifecycle management, and/or labelling activities.\nAbility to work autonomously and provide operational support with minimal onboarding.\nStrong organizational skills, attention to detail, and ability to manage multiple priorities.\nExperience with regulatory tools such as Vault RIM, XEVMPD, LIFT, and/or TVT is a strong asset.\nKnowledge of medical device regulations and clinical trial labelling is desirable.\nExperience with Compassionate Use and Medical Need Programs is a plus.\nFluency in English and preferably French and/or Dutch; German is considered an advantage.\nBenefits\nWhy Join Us?\nAt Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.\nHere’s what makes us unique.\nWe are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering 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.\nExcelling with care means 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.","description_format":"text","description_chars":3378,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-19T11:49:37Z"}],"visa":[],"liveness":{"score":75,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.838,"p_room":0.9,"age_days":14,"expected_fill_days":31,"reasons":["conf:1","win:mid"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/excelya-regulatory-affairs-officer","json_url":"https://alion.io/job/excelya-regulatory-affairs-officer.json","meta":{"generated_at":"2026-11-03T07:35:19Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":10811,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4705},"rest":"https://alion.io/mcp/rest/get_company?id=4705"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fexcelya-regulatory-affairs-officer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fexcelya-regulatory-affairs-officer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fexcelya-regulatory-affairs-officer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/excelya-regulatory-affairs-officer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fexcelya-regulatory-affairs-officer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2847525}},{"tool":"search_jobs","arguments":{"company":"excelya.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2847525},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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