{"id":3321928,"url":"https://alion.io/job/amgen-regulatory-affairs-mgr-2","title":"Regulatory Affairs Mgr","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":347,"ghost_share":0,"stale_share":0.571,"repost_share":0.012,"time_to_fill_p50_days":43,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Biotech","role_family":"Biotech","seniority":"staff","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":67000,"max_usd":130000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":35},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-10-27T08:24:27Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-31T23:17:41Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Career Category\nRegulatoryJob Description\nHOW MIGHT YOU DEFY IMAGINATION?\nAmgen is a global leader in biotechnology with a history of more than four decades of pioneering breakthroughs. Our commitment to science has led us to discover and develop innovative therapies that significantly improve patients' lives. We also invest in cutting-edge manufacturing and support services to deliver these therapies worldwide. Japan and the Asia Pacific (JAPAC) region represent the fastest-growing area for Amgen. We are currently seeking a qualified candidate for the role of Japan Regulatory Strategy Manager (Regulatory Affairs Mgr).\nLive\nWhat you will do:\nJapan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and global regulatory strategy.\nMain Responsibilities\nThe Japan Regulatory Strategy Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen’s commercialization process; and continuously improving business processes.\nThe Japan Regulatory Strategy Mgr may be assigned to multiple Amgen products for product-specific activities.\nThe Japan Regulatory Strategy Mgr has high level English language skills, deep SME Japan regulatory requirements and strong interpersonal skills with ability to influence and engage.\nWork closely with Global Regulatory Lead to integrate Japan regulator strategy into Global regulatory strategy.\nKey Activities\nStrategy and Execution\nDevelops and implements the Japan regulatory strategy, aligned with global regulatory strategy as much as possible.\nProvides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals.\nProactively influence developing the global regulatory strategy so that Japan developments are aligned.\nConsistently look for opportunities to accelerate the developments/approval and/or increase the value of the program to serve for more patients.\nAs a representative of the Japan Regulatory Strategy Group, contributes to the filing plan by advising and discussing with the local and global cross-functional teams.\nLeads the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan according to the filing plan.\nEnsures that regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.\nCollaborates with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements.\nEnsures that local labels are developed and maintained in line with local regulations and Amgen standards and procedures.\nProactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen\nLead process standardization/simplification to improve efficiency in regulatory processes\nConsistently demonstrate Amgen leadership behaviors\nInfluence developing global regulatory strategies so that Japan development strategies are aligned.\nIncrease visibility of RA Japan.\nProvide strong supports to the Japan Regulatory Strategy Group Head.\nCommunication and Collaboration\nWorks cross-functionally with the various Amgen teams related to NDAs, PMDA consultations and CTNs, etc.\nCommunicates clearly and in a timely manner with key stakeholders across the business.\nProvides subject matter expert support for local, regional, and global initiatives.\nHealth Authority (HA) Interaction\nActs as the primary interface with MHLW and PMDA for product approval and clinical development.\nLeads and contributes to strategy for HA interactions.\nAttends HA meetings.\nDevelops and maintain a good relationship with HAs in Japan to facilitate drug approvals.\nExternal Interactions\nEngages with local trade associations to shape the external environment, monitors national legislation, and provides feedback to global and local colleagues in a timely manner.\nCompliance\nMaintains regulatory compliance for all documents submitted to HA and post-approval commitments.\nSupports the monitoring, auditing, and self-assessment activities under the compliance framework.\nContributes to the development and implementation of country-specific compliance procedures and working practices.\nWin\nWhat we expect of you:\nQualifications\nBasic\nBachelor’s degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs\nPreferred\nAdvanced degree preferred\nIn-depth regulatory experience\nKnowledge of Japan legislation and regulations relating to medicinal products\nKnowledge of drug development Scientific/Technical Excellence\nTeamwork\nCommunication skills both oral and written\nAbility to understand and communicate scientific/clinical information\nKnowledge and Skills\nAbility to lead effective teams\nAbility to work in matrix environments including cross-functional and global teams\nAbility to work under minimal direction with a medium degree of autonomy\nAnalytical skills to evaluate and interpret complex situations and problems\nAbility to anticipate and prevent potential problems.\nAbility to independently develop solutions that are thorough, practical, and consistent with functional objectives\nUnderstanding of regulatory activities and how they affect projects and processes\nAbility to understand and communicate scientific and clinical information\nOrganizational, communication, and time management skills needed to manage multiple assignments and processes\nCommunication skills in English (TOEIC score ≥860 desirable)\nNative level Japanese\nComputers: Microsoft Outlook, Word, Excel, Power Point, and communication tools\nThrive\nWhat you can expect of us:\nAs we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.\nVast opportunities to learn and move up and across our global organization\nDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act\nGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits\nApply now for a career that defies imagination.\nIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.\ncareers.amgen.com\nEqual Opportunity Statement\nAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.\nWe will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.\n.","description_format":"text","description_chars":7190,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Japanese","level":"All levels","optional":true},{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Japan","iso":"JP","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T08:24:27Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":43,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/amgen-regulatory-affairs-mgr-2","json_url":"https://alion.io/job/amgen-regulatory-affairs-mgr-2.json","meta":{"generated_at":"2026-11-01T01:29:58Z","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":2351,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-regulatory-affairs-mgr-2"},{"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%2Famgen-regulatory-affairs-mgr-2"},{"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%2Famgen-regulatory-affairs-mgr-2"},{"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/amgen-regulatory-affairs-mgr-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-regulatory-affairs-mgr-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3321928}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3321928},"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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