{"id":424141,"url":"https://alion.io/job/amgen-regulatory-affairs-manager","title":"Regulatory Affairs Manager","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":"B","score":83,"open_postings":336,"ghost_share":0,"stale_share":0.682,"repost_share":0.018,"time_to_fill_p50_days":42,"computed_at":"2026-11-10T06:52:35Z"}},"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":["Breda, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":75000,"max_usd":169000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":346},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-08-04T00:00:00Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-10T05:00:42Z","board_verified":true,"closed_at":null,"days_open":98,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":98},"description":"Career Category\nRegulatoryJob Description\nIf you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:\nREGULATORY AFFAIRS MANAGER\nAt Amgen Breda medicines are labelled, assembled,storedand eventually shipped to various countries worldwide. Every day more than 1000 people with42different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.\nLIVE\nWhat you will do\nIn this vital role you will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans.\nThe primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements and preparation CMC sections of annual reports of minor changes for specific products.\nYou will also act as key Regulatory Affairs (RA)-CMC representative for managing change control, deviations and serve as the point of contact for communications with business partners and global regulatory authorities for requests related to the site.\nSpecific responsibilities include but are not limited to:\nSupport the develop and implementation of regulatory strategies as they relate to changes at the site.\n\nLead submission process for site initiatives\n\nProvide strategic expertise regarding regulatory requirements for manufacturing related projects.\n\nCollaborate with Regulatory Authorities as appropriate and in coordination with Global and International representatives.\n\nSupport regulatory authority inspections as required by Site Quality Compliance.\n\nServe as RA - CMC representative on Cross Functional Teams.\n\nLead or collaborate in the creation site related regulatory components for global submissions.\n\nSupport the generation of facility and GMP related documents to be used in product registrations activities.\n\nReview and approve regulatory documents.\n\nReview and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.\n\nMaintain facility related files.\n\nDevelop and maintain regulatory awareness through meetings, conferences and regulatory contacts.\n\nWIN\nWhat we expect of you\nWe are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs Manager professional we seek is a strong leader with these qualifications.\nDoctorate degree / Master’s degree and 3 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry\nOR Bachelor’s degree and at least 5 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry\nEducational background in Biology, Biotechnology, Microbiology or Chemistry\n\nExperience managing change control and regulatory submissions\n\nStrong oral and written communication skills in English and Dutch\n\nStrong negotiating and leadership skills\n\nExperience managing project timelines is desirable\n\nProficiency working with teams at different levels and company locations\n\nAble to operate in a fast paced, dynamic environment\n\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. Therefore, Amgen is regularly recognized as a Best PlaceToWork ©.\nVast opportunities to learn and move up and across our global organization.\n\nDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.\n\nGenerous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.\n\nFocus on vitality with an on-site gym, vitality program and a restaurant with healthy food.\n\n.","description_format":"text","description_chars":4249,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Health insurance"],"hiring_locations":[{"name":"Netherlands","iso":"NL","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Prescription Drugs","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-06T04:32:58Z"},{"event":"close","at":"2026-10-23T23:49:40Z"},{"event":"reopen","at":"2026-10-27T10:55:12Z"}],"visa":[],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.512,"p_room":0.28,"age_days":98,"expected_fill_days":42,"reasons":["conf:1","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/amgen-regulatory-affairs-manager","json_url":"https://alion.io/job/amgen-regulatory-affairs-manager.json","meta":{"generated_at":"2026-11-10T09:00:38Z","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":20943,"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-regulatory-affairs-manager"},{"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%2Famgen-regulatory-affairs-manager"},{"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%2Famgen-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/amgen-regulatory-affairs-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-regulatory-affairs-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":424141}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":424141},"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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