{"id":3164951,"url":"https://alion.io/job/ritedose-regulatory-affairs-manager","title":"Regulatory Affairs Manager","company":{"id":3784845,"name":"Ritedose","domain":"ritedose.com","url":"https://alion.io/company/ritedose","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paycom","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Columbia, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":111000,"max_usd":218000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":115},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-23T17:03:24Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-28T00:29:20Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Job Description:\nThe Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.\n***We will only consider candidates that either live in or will relocate to one of the following states: SC, AL, FL, IL, MO\nResponsibilities:\nProvide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.\nServe as primary RA contact on project teams to support product development.\nFormat, publish, and submit documentation to the FDA for initial and lifecycle submissions.\nRespond to FDA queries and deficiencies.\nProvide guidance to RA Specialists and aid in development of team.\nDevelop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.\nMonitor and interpret new and evolving regulations and assess impact on company products.\nDraft, review, and finalize product labeling for ANDA submissions, including structured product labeling.\nOversee adverse event reporting process and ensure compliance with reporting requirements.\nSupport due diligence activities, licensing, and partnerships.\nQualifications:\nBachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field\n5+ years Regulatory Affairs experience\nExperience submitting NDA/ANDAs to US FDA required, including writing and compiling eCTD compliant Modules 1, 2, and 3\nHighly detail-oriented and possess considerable problem-solving and organization skills\nAbility to work on complex projects and take initiative with general direction and minimal guidance\nAbility to be flexible with a change in priorities\nExcellent written, verbal, and listening skills, must work well with others\nExperience using an electronic document control system\nExperience with publishing using eCTD publishing software preferred\nProficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat\nQualifications\nBachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field \n5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred \nHighly detail-oriented and possess considerable problem-solving and organization skills \nAbility to work on complex projects and take initiative with general direction and minimal guidance\nAbility to be flexible with a change in priorities \nExcellent written, verbal, and listening skills, must work well with others\nExperience using an electronic document control system\nExperience with eCTD publishing software preferred\nProficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat","description_format":"text","description_chars":2979,"description_truncated":false,"requirements":{"experience_years_min":5,"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"},{"name":"Florida","iso":null,"kind":"city"},{"name":"Illinois","iso":null,"kind":"city"},{"name":"Missouri","iso":null,"kind":"city"},{"name":"Alabama","iso":null,"kind":"city"},{"name":"South Carolina","iso":null,"kind":"city"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Generic Drugs","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-23T17:03:24Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":16,"reasons":["conf:5","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/ritedose-regulatory-affairs-manager","json_url":"https://alion.io/job/ritedose-regulatory-affairs-manager.json","meta":{"generated_at":"2026-10-28T09:05:23Z","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":11794,"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":3784845},"rest":"https://alion.io/mcp/rest/get_company?id=3784845"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fritedose-regulatory-affairs-manager"},{"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%2Fritedose-regulatory-affairs-manager"},{"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%2Fritedose-regulatory-affairs-manager"},{"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/ritedose-regulatory-affairs-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fritedose-regulatory-affairs-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3164951}},{"tool":"search_jobs","arguments":{"company":"ritedose.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3164951},"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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