{"id":417922,"url":"https://alion.io/job/excelya-regulatory-affairs-project-manager-pharmacist","title":"Regulatory Affairs Project Manager (Pharmacist)","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":29,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Management","role_family":"Management","seniority":"senior","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":{"min_usd":49000,"max_usd":73000,"period":"year","method":"role_seniority_country_cell","sample_n":136},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-08-10T00:00:00Z","employer_posted_date":"2026-08-10","last_verified_at":"2026-10-23T17:24:55Z","board_verified":false,"closed_at":"2026-10-23T17:24:55Z","days_open":74,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":74},"description":"At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Global Regulatory Submission Manager Consultant to join our dynamic team.\nThis role is responsible for leading and coordinating global regulatory submission activities across the entire product lifecycle, from First-in-Human (FIH) development through post-approval maintenance and license withdrawal. As a key member of the Global Regulatory Team, you will drive submission planning and execution, ensuring high-quality dossiers are delivered on time and in compliance with global regulatory requirements across major markets including the FDA, Europe, China, and Japan.\nThe Regulatory Affairs Department is looking for a senior consultant with strong expertise in regulatory operations, dossier management, and global submission coordination\nKey responsibilities :\nLead the planning, coordination, and execution of global regulatory submission strategies across key markets (FDA, EU, China, and Japan).\nManage dossier preparation, compilation, and submission activities, ensuring compliance with regulatory requirements and timelines.\nCoordinate interactions with external service providers and publishing vendors to ensure successful dossier delivery and submissions.\nIdentify submission risks, proactively address resource constraints, and support problem-solving to maintain project timelines.\nDrive regulatory submission activities throughout the entire product lifecycle, from First-in-Human (FIH) studies to license withdrawal.\nPartner with Global Regulatory Leads, Regional Regulatory Leads, and cross-functional teams to develop and execute global regulatory roadmaps.\nBuild and maintain project management tools, submission schedules, dashboards, and milestone tracking to support regulatory governance.\nOversee the preparation of reference dossiers (Modules 2-5), ensuring alignment across global and local regulatory requirements.\nMonitor submission progress, manage dossier updates, coordinate responses to health authority questions, and ensure regulatory database compliance.\nAct as a key member of the Global Regulatory Team, collaborating closely with Medical Writing, Clinical Development, R&D Operations, Technical Management, and external industry partners.\nRequirements\nProven experience in global regulatory submissions and regulatory operations\nStrong knowledge of eCTD dossier preparation, publishing, and submission processes\nExperience with FDA, EMA, China, and Japan regulatory requirements\nExcellent project management and stakeholder coordination skills\nAbility to manage multiple priorities and meet challenging deadlines\nStrong risk assessment and problem-solving capabilities\nExperience working in cross-functional and international environments\nProactive, organized, and detail-oriented mindset\nExcellent communication and collaboration skills\nFluent in English (written and spoken)\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":3727,"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":["Pharmacies","Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-09-06T03:27:52Z"},{"event":"close","at":"2026-10-23T17:24:55Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/excelya-regulatory-affairs-project-manager-pharmacist","json_url":"https://alion.io/job/excelya-regulatory-affairs-project-manager-pharmacist.json","meta":{"generated_at":"2026-10-26T02:19:02Z","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":3097,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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-project-manager-pharmacist"},{"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-project-manager-pharmacist"},{"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-project-manager-pharmacist"},{"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-project-manager-pharmacist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fexcelya-regulatory-affairs-project-manager-pharmacist"}]}