{"id":3118770,"url":"https://alion.io/job/verastem-regulatory-affairs-associate","title":"Regulatory Affairs Associate","company":{"id":3103116,"name":"Verastem Oncology","domain":"verastem.com","url":"https://alion.io/company/verastem","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"BambooHR","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","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":73000,"max_usd":154000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":132},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Veeva","optional":true}],"status":"closed","first_seen_at":"2026-10-22T23:31:43Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-28T20:05:13Z","board_verified":false,"closed_at":"2026-10-28T20:05:13Z","days_open":5,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":5},"description":"Company Profile:\nAt Verastem Oncology, we address urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve launched this novel/novel combination therapy in the U.S. and are exploring pathways for Europe and Japan. We continue to advance our pipeline of drugs to help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. This is an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.\nPosition Summary\nThe Regulatory Affairs Associate supports the preparation, submission, and maintenance of regulatory documents for pharmaceutical products. The associate works closely with various stakeholders including regulatory, quality, clinical, and technical teams, to assist in keeping submission materials accurate, organized, traceable, and ready for review. This role is suited to a recent graduate with relevant internship or co-op experience in regulatory affairs or pharmaceutical quality.\nCore Responsibilities\nAssist with compiling, formatting, quality checking, and tracking documents for FDA submissions, including investigational new drug (IND), new drug application (NDA) submissions and amendments, as applicable to the company’s portfolio.\nPartner with Regulatory Advertising and Promotion to prepare, quality check, publish, and track FDA promotional material submissions, including Form FDA 2253 and applicable pre-dissemination submissions, while maintaining accurate submission records and acknowledgments.\nMaintain regulatory submission logs, document inventories, timelines, and electronic records; check materials for completeness, version control, and consistency before review.\nSupport preparation and updating of regulatory forms, correspondence, and supporting documents under the guidance of senior regulatory staff.\nCoordinate with clinical, quality, manufacturing, and other contributors to collect documents, follow up on comments, and support submission deadlines.\nMonitor and summarize relevant FDA guidance, regulatory developments, and publicly available review findings to help the team identify recurring issues and potential submission risks.\nSupport controlled-document activities, including drafting or revising standard operating procedures and tracking review and approval in electronic document systems.\nApply good documentation practices, data integrity principles, and applicable current good manufacturing practice (cGMP) requirements when handling regulated records.\nEscalate missing information, discrepancies, and potential compliance concerns to the appropriate team member.\nAnticipated travel of 3 consecutive weekdays per month to the Verastem Corporate Office in MA.\nRequired Education and Experience\nBachelor’s degree in biochemistry, biotechnology, biology, pharmaceutical sciences, pharmacy, regulatory or life science.\nEntry-level experience; relevant internships, co-ops, or academic projects in regulatory affairs, pharmaceutical quality, biotechnology, or a regulated laboratory count as experience.\nExposure to regulated documentation, such as submission records, quality records, standard operating procedures, specifications, or investigation records.\nStrong attention to detail, clear written communication, sound organization, and the ability to coordinate with colleagues across functions.\nProficiency with Microsoft Word and Excel and the ability to learn electronic regulatory and quality document systems.\nFoundational understanding of FDA regulatory processes, good documentation practices, data integrity, and cGMP principles.\nPreferred qualifications\nHands-on exposure to FDA submission support, or IND documentation.\nExperience with Veeva RIM, Veeva QualityDocs, or similar systems.\nExperience reviewing controlled documents, maintaining traceable electronic records, analyzing quality or regulatory trends, or presenting findings to colleagues.","description_format":"text","description_chars":4175,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Drug Discovery","Cancer Care Centers"],"lifecycle":[{"event":"open","at":"2026-10-22T23:31:43Z"},{"event":"close","at":"2026-10-28T20:05:13Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":167500,"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":null,"pay":null,"html_url":"https://alion.io/job/verastem-regulatory-affairs-associate","json_url":"https://alion.io/job/verastem-regulatory-affairs-associate.json","meta":{"generated_at":"2026-11-02T02:01:05Z","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":3031,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":3103116},"rest":"https://alion.io/mcp/rest/get_company?id=3103116"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fverastem-regulatory-affairs-associate"},{"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%2Fverastem-regulatory-affairs-associate"},{"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%2Fverastem-regulatory-affairs-associate"},{"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/verastem-regulatory-affairs-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fverastem-regulatory-affairs-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3118770}},{"tool":"search_jobs","arguments":{"company":"verastem.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3118770},"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); 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