{"id":1292414,"url":"https://alion.io/job/monterosatx-manager-regulatory-affairs","title":"Manager, Regulatory Affairs","company":{"id":2011003,"name":"MonteRosaTx","domain":"monterosatx.com","url":"https://alion.io/company/monterosatx","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","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":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":106000,"max_usd":186000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Outlook","optional":false},{"name":"Windows","optional":false}],"status":"live","first_seen_at":"2026-09-26T08:15:18Z","employer_posted_date":"2026-09-26","last_verified_at":"2026-10-31T17:47:09Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":35},"description":"Overview\nResponsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/interpretations. May determine methods and procedures on some assignments and may provide guidance to other lower-level personnel.\nResponsibilities\nCoordinates regulatory workflow, provides regulatory support to the team, and tracks project timelines and budget.\nProvides ongoing regulatory support to the project team members.\nUnder supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.\nReviews and formats technical documents (pertaining to clinical, chemistry, manufacturing and controls, and non-clinical information). This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.\nParticipates in assigned Regulatory Affairs initiatives aimed at improving internal Idenix standards and tracking/control systems.\nDevelops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes.\nResearches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.\nDirect interaction with regulatory agencies on routine matters.\nQualifications\nBachelors/Masters Degree in a scientific discipline or equivalent with a minimum 8 years of Regulatory Affairs experience.\nMust have extensive experience and understanding of CMC requirements for Small Molecule drugs.\nPrior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines.\nA working knowledge of electronic publishing and file management systems, preferred.\nExcellent understanding of Microsoft Windows, Office, Excel, Project, Outlook, and other common PC applications.\nExcellent organizational, presentation, and decision-making skills, and analytical thinking/problem-solving/investigative skills are required.\nCertified regulatory affairs professional would be desirable","description_format":"text","description_chars":2246,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care"],"lifecycle":[{"event":"open","at":"2026-09-26T08:15:18Z"}],"visa":[],"liveness":{"score":40,"band":"fade","label":"Fading","p_open":1,"p_active":0.724,"p_room":0.55,"age_days":34,"expected_fill_days":29,"reasons":["conf:3","win:tail"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/monterosatx-manager-regulatory-affairs","json_url":"https://alion.io/job/monterosatx-manager-regulatory-affairs.json","meta":{"generated_at":"2026-10-31T19:16:20Z","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":30298,"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":2011003},"rest":"https://alion.io/mcp/rest/get_company?id=2011003"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmonterosatx-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%2Fmonterosatx-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%2Fmonterosatx-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/monterosatx-manager-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmonterosatx-manager-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1292414}},{"tool":"search_jobs","arguments":{"company":"monterosatx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1292414},"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"}}