{"id":3049461,"url":"https://alion.io/job/erasca-exec-directorvp-regulatory-affairs","title":"Exec Director/VP Regulatory Affairs","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":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","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":275000,"max":355000,"currency":"USD","period":"year","gross":null,"usd_annual":355000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-10-22T00:23:27Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-28T15:46:41Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"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 Executive Director or VP, Regulatory Affairs will lead regulatory strategy for defined disease area and develop and execute global regulatory strategies and submissions from pre-IND through regulatory approval to launch, commercialization, and product lifecycle management.\nNote that this position can be hybrid in San Diego, CA or South San Francisco, CA or fully remote anywhere in the United States.\nEssential Duties and Responsibilities:\nRepresent regulatory on program and study teams and in disease area strategy and planning meetings\nWorking with the team, develop regulatory strategies to ensure development plans are comprehensive and comply with regulatory requirements\nLead or support preparation and review of regulatory documents (e.g., IND, CTA/IMPD, DSUR, pre-meeting briefing document, iPSP/PIP, NDA, sNDA), including oversight of regulatory submissions to assure technical accuracy and completeness\nAct as Regulatory Affairs representative in business development and due diligence activities\nReview relevant clinical documents for scientific content and regulatory compliance\nAct as primary liaison with the FDA and OUS health authorities to facilitate timely review and approval of regulatory submissions and lead regulatory milestone discussions (e.g., pre-IND, End-of-Phase, pre-NDA meetings, EU Scientific Advice)\nPlan and direct regulatory activities through regulatory staff and cross functional teams\nProvide regulatory support for company compliance initiatives\nRegulatory support and guidance for regulatory audits and/or inspections\nRegulatory oversight of service providers and regulatory consultants\nLead and support continued development of new systems and processes to improve efficiency for the regulatory department in a growing organization\nKeep current on US and OUS regulations that apply to company products and processes\nPerform all duties in keeping with the Company’s core values, policies and all applicable regulations\nRequired Education and Experience:\nUndergraduate degree required; advanced degree preferred\n10+ years of relevant experience in pharma or biotech regulatory affairs required, including deep expertise in global regulatory strategy from pre-IND through NDA and post approval\nProven knowledge and experience in US and EU regulatory affairs required (e.g., IND, CTA, CTN, NDA) and leading formal interactions with health authorities (e.g., pre IND, End-of-Phase, Scientific Advice, etc)\nExperience with NDA submission and product approval preferred\nExperience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy Designation, PRIME, a plus\nProven knowledge of FDA and ICH guidelines\nAbility to translate regulatory requirements into practical workable plans\nStrong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail\nEffective interpersonal, communication and influencing skills, including excellent writing skills\nExperience leading, mentoring, and developing direct reports\nDemonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.\nStrong learning orientation, curiosity, and commitment to science and patients\nTheanticipatedsalaryrangeforthis position is$275,000 to $355,000.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":5614,"description_truncated":false,"requirements":{"experience_years_min":10,"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":6,"expected_fill_days":48,"reasons":["conf:4","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":355000,"is_top_pay":true},"html_url":"https://alion.io/job/erasca-exec-directorvp-regulatory-affairs","json_url":"https://alion.io/job/erasca-exec-directorvp-regulatory-affairs.json","meta":{"generated_at":"2026-10-28T17:24:47Z","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":23675,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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-exec-directorvp-regulatory-affairs"},{"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-exec-directorvp-regulatory-affairs"},{"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-exec-directorvp-regulatory-affairs"},{"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-exec-directorvp-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ferasca-exec-directorvp-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3049461}},{"tool":"search_jobs","arguments":{"company":"erasca.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3049461},"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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