{"id":1644114,"url":"https://alion.io/job/fatetherapeutics-senior-manager-regulatory-affairs-cmc","title":"Senior Manager, Regulatory Affairs CMC","company":{"id":2533316,"name":"Fate Therapeutics","domain":"fatetherapeutics.com","url":"https://alion.io/company/fatetherapeutics","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":110000,"max_usd":207000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":222},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-17T18:45:43Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-10-18T15:21:42Z","board_verified":true,"closed_at":null,"days_open":30,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":30},"description":"Fate Therapeutics is looking for Senior Manager, Regulatory Affairs CMC to help advance innovative cell therapy products from early development through licensure. In this role, you will shape global CMC regulatory strategy, lead high-quality submissions, partner across technical and quality teams, and contribute to health authority interactions. The ideal candidate is a collaborative regulatory professional with strong CMC expertise, biotechnology or pharmaceutical experience, sound judgment, and the communication skills to influence cross-functional teams in a fast-paced, mission-driven environment.This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.\nResponsibilities\nServe as the Regulatory Affairs CMC lead on cross-functional project teams, providing global regulatory guidance to support successful product development.\nDevelop and execute Regulatory CMC strategies for cell therapy products from early development through licensure.\nLead preparation and review of CMC submission documents and dossiers for global health authorities, including briefing packages and IND, IMPD, BLA, and MAA filings.\nAuthor and lead responses to health authority CMC-related queries in collaboration with relevant functions.\nPartner with CMC, analytical, process, quality, research, and regulatory teams to deliver high-quality submissions and query responses.\nProvide regulatory assessments for CMC changes through change control activities.\nTrack regulatory CMC commitments to health authorities.\nSupport product and package labeling maintenance to meet global regulatory requirements.\nMonitor and interpret current and emerging global regulations, guidelines, and precedents relevant to the company’s products and therapeutic areas to support compliance and continuous improvement.\nDevelop and maintain contingency plans for issues affecting product registration, regulatory compliance, or lifecycle management.\nProactively identify, assess, and escalate CMC regulatory issues and risks; develop mitigation strategies across FATE’s product pipeline.\nContribute to continuous improvement of Regulatory Affairs processes, templates, and best practices to enhance quality, efficiency, and compliance.\nQualifications\nBachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences required; advanced degree (M.S., Ph.D., or Pharm.D.) preferred.\nMinimum 7 years of progressive Regulatory Affairs or other relevant CMC experience in the pharmaceutical or biotechnology industry.\nStrong knowledge of global health authority regulations, guidelines, and submission pathways.\nDemonstrated success leading regulatory submissions and documentation.\nExperience with biologics and/or cell and gene therapies, such as CAR-T, AAV, or CRISPR, preferred.\nExperience with Veeva Vault RIM and QMS systems a plus.\nExcellent verbal and written communication skills, including the ability to present and defend regulatory strategies cross-functionally.\nExceptional attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines.\nAdaptable, with the ability to quickly absorb and apply new technical and strategic information.\nWorking Conditions & Physical Requirements\nOccasional travel may be required (up to 10%).\nSubject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.\nCompensation\nThe salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.\nFate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.\nThe anticipated salary range for this role is $160,000 - $190,000.","description_format":"text","description_chars":3723,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-01T22:59:06Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":122500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":59,"band":"ok","label":"Likely open","p_open":1,"p_active":0.787,"p_room":0.75,"age_days":29,"expected_fill_days":30,"reasons":["conf:2","urgency","win:late"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/fatetherapeutics-senior-manager-regulatory-affairs-cmc","json_url":"https://alion.io/job/fatetherapeutics-senior-manager-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-10-18T15:30:58Z","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":21387,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-19T00:00:00Z"}},"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":2533316},"rest":"https://alion.io/mcp/rest/get_company?id=2533316"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffatetherapeutics-senior-manager-regulatory-affairs-cmc"},{"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%2Ffatetherapeutics-senior-manager-regulatory-affairs-cmc"},{"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%2Ffatetherapeutics-senior-manager-regulatory-affairs-cmc"},{"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/fatetherapeutics-senior-manager-regulatory-affairs-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffatetherapeutics-senior-manager-regulatory-affairs-cmc"}]}