{"id":399130,"url":"https://alion.io/job/avalynpharma-senior-manager-regulatory-affairs","title":"Senior Manager, Regulatory Affairs","company":{"id":9864,"name":"Avalynpharma","domain":"avalynpharma.com","url":"https://alion.io/company/avalynpharma","size_band":"201-500","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":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States","United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":157000,"max":173000,"currency":"USD","period":"year","gross":null,"usd_annual":173000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-08-17T22:11:15Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-27T12:42:10Z","board_verified":true,"closed_at":null,"days_open":70,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":70},"description":"About Avalyn:\nAvalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.\nPosition Summary:\nThe Senior Manager, Regulatory Affairs will support the development and execution of the global regulatory strategy and execution for Avalyn’s development-stage, inhaled drug-device combination products. Reporting to the SVP, Regulatory Affairs, this position will contribute to global regulatory submissions, health authority interactions, and cross-functional regulatory planning to support product development activities. This role is well suited for a highly motivated regulatory professional who is looking to expand their regulatory leadership capabilities while supporting programs from early stages through late-phase clinical development.\nThe Senior Manager will primarily support senior regulatory leadership in the planning and execution of regulatory activities across the development pipeline. The role will contribute to regulatory initiatives that promote consistency, operational excellence, and compliance across programs, including support for regulatory processes, systems, and standards. As experience and responsibilities grow, the individual will have the opportunity to assume increasing ownership of an assigned development program under guidance of senior regulatory leadership. This position will work collaboratively across functions to help ensure high-quality regulatory deliverables and effective interactions with global health authorities.\nResponsibilities:\nStrategic & Regulatory Program Support\nSupport the development and execution of global regulatory strategies across nonclinical, clinical, CMC, and device components for Avalyn's development programs.\nTranslate regulatory strategy into actionable plans, timelines, and deliverables.\nIdentify regulatory risks and support development of mitigation strategies in partnership with senior regulatory leadership.\nProvide regulatory support across multiple development programs and portfolio initiatives.\nRegulatory Filings & Health Authority Interactions\nCoordinate preparation, review, and submission of regulatory filings, including INDs, CTAs, amendments, annual reports, orphan drug applications, briefing packages, and other global submissions.\nAuthor and/or contribute to key regulatory documents and submission content.\nSupport Phase 3 and marketing application readiness activities.\nSupport regulatory meetings and interactions with FDA and other global health authorities, including preparation of responses and follow-up activities.\nEnsure submissions and regulatory communications are high quality, compliant, and delivered on time.\nRegulatory Operations, Systems, & Compliance\nMaintain regulatory tracking systems, dashboards, and tools used to manage submissions, commitments, correspondence, and key milestones.\nSupport organization and maintenance of Regulatory Affairs documentation within SharePoint and other document management systems.\nManage regulatory operational activities, including submission tracking, document management, compliance reporting, and archiving.\nMonitor evolving regulatory requirements and contribute to process improvements, standards, and best practices that support compliance and operational excellence.\nMay serve as regulatory lead for selected routine agency interactions under senior oversight.\nCross-Functional Collaboration & Team Contribution\nWork closely with Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management teams to ensure regulatory considerations are integrated into program plans.\nParticipate in cross-functional project teams as the regulatory representative for assigned programs and development activities.\nContribute to a collaborative and high-performing regulatory environment and provide guidance to junior team members as appropriate.\nBuild increasing responsibility for assigned development programs over time under the guidance of senior regulatory leadership.\nQualifications:\nA minimum of a Bachelor’s degree is required; an Advanced degree (e.g., MS, PharmD, PhD, etc.) or regulatory affairs training/certification is preferred\nA minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry, with operational support of global clinical trials, and direct authorship of regulatory submissions for investigational and commercial products.\nExperience supporting global development programs across one or more stages of clinical development, with hands-on preparation and maintenance of regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, and health authority meeting materials).\nWorking knowledge of drug-device combination products and their unique regulatory considerations is desirable.\nSolid understanding of U.S. FDA regulations, ICH guidelines, and eCTD submission requirements; experience with orphan drug, expedited, or other special regulatory pathways is a plus.\nExperience supporting regulatory interactions with FDA and/or other global health authorities.\nDemonstrated ability to collaborate effectively within cross-functional teams, including Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management.\nStrong project management, organizational, and communication skills, with demonstrated ability to manage multiple priorities and deadlines in a fast-paced environment.\nExperience with regulatory information management systems, document management platforms, and/or SharePoint preferred.\nExperience in a small biotechnology company or matrixed environment is desirable.\nProposed pay range\n$157,000—$173,000 USD","description_format":"text","description_chars":7064,"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"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-06T00:21:49Z"}],"visa":[],"liveness":{"score":25,"band":"fade","label":"Fading","p_open":1,"p_active":0.683,"p_room":0.36,"age_days":70,"expected_fill_days":38,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":173000,"is_top_pay":false},"html_url":"https://alion.io/job/avalynpharma-senior-manager-regulatory-affairs","json_url":"https://alion.io/job/avalynpharma-senior-manager-regulatory-affairs.json","meta":{"generated_at":"2026-10-27T15:45:00Z","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":4756,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":9864},"rest":"https://alion.io/mcp/rest/get_company?id=9864"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Favalynpharma-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%2Favalynpharma-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%2Favalynpharma-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/avalynpharma-senior-manager-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Favalynpharma-senior-manager-regulatory-affairs"}]}