{"id":1941332,"url":"https://alion.io/job/gilead-sciences-senior-regulatory-affairs-manager","title":"Senior Regulatory Affairs Manager","company":{"id":8130,"name":"Gilead Sciences","domain":"gilead.com","url":"https://alion.io/company/gilead","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":12,"ghost_share":0,"stale_share":0.333,"repost_share":0.167,"time_to_fill_p50_days":41,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tokyo, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":52000,"max_usd":120000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":302},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-06T03:16:08Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-11-02T04:24:15Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.\nEvery member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.\nWe believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.\nJob Description\nRepresents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams. \nWith guidance, defines the regulatory strategy for one or more Gilead/Kite products or projects. \nEvaluates changes to the local regulatory landscape and sharing risks and opportunities with the global study team when necessary.\nProactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans. \nLeads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Clinical Trial Notification (CTN). \nLeads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for new drug submission, etc. \nProvides input to the content of the original label and label updates. \nEnsures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets. \nContributes to process improvements and/or other special projects within Regulatory Affairs. \nEnsures own work complies with established practices, policies and processes, and any regulatory or other requirements.\nFor Current Gilead Employees and Contractors:\nPlease apply via the Internal Career Opportunities portal in Workday.","description_format":"text","description_chars":2606,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Japan","iso":"JP","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-06T03:16:08Z"}],"visa":[],"liveness":{"score":78,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.871,"p_room":0.9,"age_days":26,"expected_fill_days":41,"reasons":["conf:11","velocity","win:mid","comp:brand"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/gilead-sciences-senior-regulatory-affairs-manager","json_url":"https://alion.io/job/gilead-sciences-senior-regulatory-affairs-manager.json","meta":{"generated_at":"2026-11-02T05:51:15Z","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":8397,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":8130},"rest":"https://alion.io/mcp/rest/get_company?id=8130"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgilead-sciences-senior-regulatory-affairs-manager"},{"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%2Fgilead-sciences-senior-regulatory-affairs-manager"},{"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%2Fgilead-sciences-senior-regulatory-affairs-manager"},{"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/gilead-sciences-senior-regulatory-affairs-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgilead-sciences-senior-regulatory-affairs-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1941332}},{"tool":"search_jobs","arguments":{"company":"gilead.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1941332},"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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