{"id":3049462,"url":"https://alion.io/job/erasca-sr-managerassoc-director-regulatory-operations","title":"Sr Manager/Assoc Director, Regulatory Operations","company":{"id":673703,"name":"Erasca","domain":"erasca.com","url":"https://alion.io/company/erasca","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":48,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States","South San Francisco, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":185000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Smartsheet","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:17:56Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-11-05T08:42:06Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutatedsignaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.\nPosition Summary:\nReporting to the Chief Regulatory Affairs Officer, the Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This individual will build and manage the Regulatory Information Management System, lead submission planning and execution, and establish efficient processes for regulatory records, document management, publishing, and health authority correspondence. The role will work closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions.\nNote this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.\nEssential Duties and Responsibilities: \nSupport Regulatory Affairs submissions including:Partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables; proactively track progress, identify risks or dependencies, and drive submission activities to completion\nMay independently lead/coordinate standardized submissions, such as DSURs, IBs, etc.\n\nSupport Regulatory Affairs Department operations, including:Maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information, including the timely update of associated trackers\nSupport periodic QC reviews of study TMFs and resolve identified documentation gaps\nEstablish and maintain Regulatory document templates, formatting standards, naming conventions, submission-ready document requirements, and archival practices\nMaintain organized and inspection-ready Regulatory repositories and archives in accordance with established document management practices\nSupport or lead management of the Regulatory department budget, including forecasts, invoices, and payment approvals\n\nPerform all duties in keeping with the Company’s core values, policies, and all applicable regulations.\nEducation and Experience\nUndergraduate degree required, advanced degree preferred; RAC certification a plus\n6+ years of relevant experience in Regulatory Operations or a closely related field; experience in a small or mid-sized company preferred\nSound knowledge of drug development strategies and regulations\nExperience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role preferred\nHands-on experience with regulatory information management or electronic document management systems and with health authority question and commitment tracking\nStrong project management skills, with the ability to manage strategic deadlines, changing requirements, multiple priorities, and operational risks\nExperience with document formatting and authoring templates, and training colleagues on business processes, RIM or EDMS practices, and submission standards\nExperience creating operational dashboards or portfolio reporting with Smartsheet, Microsoft 365, or comparable tools\nDemonstrated interest and ability to learn new things; develops solutions to technical problems and drives change\nAble to work in an entrepreneurial, fast paced, dynamic, team-oriented environment\nStrong learning orientation, curiosity, and commitment to science and patients\nTheanticipatedsalaryrangeforthis position is$185,000 to $200,000.Thefinalsalaryofferedtoasuccessfulcandidatewillbedependentonseveralfactorsthatmayincludebutarenotlimitedtothetypeandlengthofexperiencewithinthejob,typeandlengthofexperiencewithintheindustry,education,etcetera.In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of theoption to purchase stock in the future for a specified price.\nAlong with our casual, collaborative,and fun work and the chance to make your mark in our mission to erase cancer, Erascaoffers a comprehensive and competitive benefits package that includes:Paid Time Off, Holiday,and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts(FSA,HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erascacontribution, and the opportunity to participate in an Employee Stock Purchase Program. \nErasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.","description_format":"text","description_chars":5419,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Precision Medicine","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-22T01:57:03Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":14,"expected_fill_days":48,"reasons":["conf:2","win:early"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":200000,"is_top_pay":false},"html_url":"https://alion.io/job/erasca-sr-managerassoc-director-regulatory-operations","json_url":"https://alion.io/job/erasca-sr-managerassoc-director-regulatory-operations.json","meta":{"generated_at":"2026-11-05T13:28:35Z","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":17503,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":673703},"rest":"https://alion.io/mcp/rest/get_company?id=673703"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ferasca-sr-managerassoc-director-regulatory-operations"},{"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%2Ferasca-sr-managerassoc-director-regulatory-operations"},{"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%2Ferasca-sr-managerassoc-director-regulatory-operations"},{"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/erasca-sr-managerassoc-director-regulatory-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ferasca-sr-managerassoc-director-regulatory-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3049462}},{"tool":"search_jobs","arguments":{"company":"erasca.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3049462},"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. Docs: https://alion.io/developers"}}