{"id":3978680,"url":"https://alion.io/job/excelya-global-regulatory-lead","title":"Global Regulatory Lead","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":95,"open_postings":5,"ghost_share":0,"stale_share":0.2,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["FR"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-09T19:01:05Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-10T00:23:51Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"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.\nTo strengthen one of our strategic partnerships, we are looking for a Global Regulatory Lead to drive global regulatory strategies and support the development and registration of innovative products worldwide.\nKey responsibilities :\nDeveloping and maintaining global regulatory strategies aligned with development and business objectives.\nAssessing evolving regulatory requirements, competitor landscapes, and regulatory intelligence across major markets.\nLeading interactions with Health Authorities, including EMA, FDA, PMDA, and other key agencies.\nDriving regulatory activities related to registrations, lifecycle management, orphan drug designation, and market expansions.\nDesigning and overseeing global submission plans in collaboration with regional regulatory teams and submission management.\nActing as a core member of global cross-functional project teams, ensuring alignment between Regulatory Affairs, Clinical Development, Safety, CMC, Market Access, and other stakeholders.\nSupporting the preparation and maintenance of CTA/IND documentation, CTD modules, briefing books, regulatory Q&A packages, PIP/PSP activities, and other key regulatory deliverables.\nLeading label development activities and contributing to Company Core Data Sheets (CCDS).\nManaging regulatory risk assessments and maintaining regulatory risk registers.\nSupporting registration activities in key markets and contributing to regulatory due diligence and licensing initiatives when required.\nEvaluating the regulatory impact of quality, efficacy, or safety findings throughout product development.\nRequirements\nAt Excelya, we encourage taking daring steps, so we seek individuals who are ready to grow with our mission and embody our values.\nEducation: Master's Degree, PharmD, PhD, MD, or equivalent scientific qualification.\nExperience: Advanced experience in Regulatory Affairs with proven expertise in global regulatory strategy, registrations, and lifecycle management within the pharmaceutical or biotechnology industry.\nTechnical Skills: Strong knowledge of global regulatory frameworks (ICH, EMA, FDA) and experience supporting product development, submissions, and regulatory interactions with Health Authorities.\nLeadership Skills: Demonstrated ability to lead cross-functional teams, influence stakeholders, and drive strategic decisions in a complex international environment.\nLangage : Fluent in English\nBenefits\nWhy join us?\nAt Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.\nHere's what makes us unique:\nWe are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.\nOur \"one-stop provider\" service model-combining full-service, functional service provider, and consulting-allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.\nExcelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.","description_format":"text","description_chars":3546,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"France","iso":"FR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-11-09T19:01:05Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":29,"reasons":["conf:4","win:early"],"computed_at":"2026-11-10T04:55:53Z"},"pay":null,"html_url":"https://alion.io/job/excelya-global-regulatory-lead","json_url":"https://alion.io/job/excelya-global-regulatory-lead.json","meta":{"generated_at":"2026-11-10T04:55:53Z","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":11478,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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-global-regulatory-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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-global-regulatory-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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-global-regulatory-lead"},{"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-global-regulatory-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fexcelya-global-regulatory-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3978680}},{"tool":"search_jobs","arguments":{"company":"excelya.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3978680},"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. Docs: https://alion.io/developers"}}