{"id":1262778,"url":"https://alion.io/job/marea-tx-senior-manager-regulatory-affairs","title":"Senior Manager, Regulatory Affairs","company":{"id":3786159,"name":"Marea Therapeutics","domain":"mareatx.com","url":"https://alion.io/company/mareatx","size_band":null,"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":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":180000,"max":195000,"currency":"USD","period":"year","gross":null,"usd_annual":195000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-07-20T13:44:16Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-31T07:30:29Z","board_verified":true,"closed_at":null,"days_open":102,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":102},"description":"ABOUT THE COMPANY\nMarea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases. \nThe company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year. \nAt Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results. \nABOUT THE ROLE\nReporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.\nThis is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.\nKEY RESPONSIBILITIES \nFormulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence\nCollaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks\nManage coordination, preparation, and timely submission of regulatory documents and filings\nReview global regulatory submissions for consistency and quality across regions\nManage preparation of responses to queries from regulatory authorities\nMaintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs\nEnsure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs\nProvide regulatory advice to other functional areas\nParticipate in regulatory due diligence activities\nRelationships\nBuild and maintain collaborative relationships with external business partners to achieve project regulatory goals\nDevelop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines\nDevelop and manage relationships with external vendors and regulatory health authorities\nManage activities for meetings and conferences with FDA, EMA, and other regulatory authorities\nManagement\nMay supervise employees and consultants/contractors in Regulatory Affairs\nDevelop and implement regulatory operating guidelines and common work practices/strategies within the team\n QUALIFICATIONS \nBachelor’s degree is required, preferably in a scientific field; advanced degree is a plus\n8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in cardiometabolic/cardiovascular or endocrinology therapeutic areas is a plus\nExcellent working knowledge of international regulatory requirements and environment, including an understanding of GXP\nDemonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions\nSolid working knowledge of core processes: discovery, development, and manufacturing\nExperience with eCTD requirements and electronic submissions\nExperience with international regulatory submissions and processes is a strong plus\nAbility to work effectively across teams, functions and with outside partners\nExcellent oral and written communication skills\nExcellent organizational skills and attention to detail\n PAY RANGE\nIn compliance with applicable pay transparency laws, the expected base salary range for this position is $180,000 to $195,000 annually. This range represents the Company's good faith estimate of the salary range for this role at the date of hire and is subject to change.\nWe do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.","description_format":"text","description_chars":5394,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-25T21:07:38Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":137500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":11,"band":"cold","label":"Long shot","p_open":1,"p_active":0.391,"p_room":0.28,"age_days":102,"expected_fill_days":28,"reasons":["conf:2","win:tail","crowd:"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":195000,"is_top_pay":true},"html_url":"https://alion.io/job/marea-tx-senior-manager-regulatory-affairs","json_url":"https://alion.io/job/marea-tx-senior-manager-regulatory-affairs.json","meta":{"generated_at":"2026-10-31T09:40:40Z","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":14662,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":3786159},"rest":"https://alion.io/mcp/rest/get_company?id=3786159"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmarea-tx-senior-manager-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%2Fmarea-tx-senior-manager-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%2Fmarea-tx-senior-manager-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/marea-tx-senior-manager-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmarea-tx-senior-manager-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1262778}},{"tool":"search_jobs","arguments":{"company":"mareatx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1262778},"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"}}