{"id":2395084,"url":"https://alion.io/job/dbv-technologies-director-regulatory-affairs-cmc","title":"Director, Regulatory Affairs CMC","company":{"id":1941434,"name":"DBV Technologies","domain":"dbv-technologies.com","url":"https://alion.io/company/dbv-technologies","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Teamtailor","truth_index":{"grade":"A","score":95,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":147,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":190000,"max":230000,"currency":"USD","period":"year","gross":null,"usd_annual":230000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-12T17:57:31Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-11-01T05:33:32Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":19},"description":"Description : \n· Responsible for the development and execution of global regulatory CMC strategies and ongoing alignment with changing regulatory and business needs. This position will provide CMC regulatory expertise and leadership for combination biologics/medical device development projects and future commercial products.\n· Lead CMC RA change control assessments, support of CDMO and QA manufacturing processes from CMC RA perspective, tracking of Heath Authority commitments, leading global submissions and compliance to global regulations.\n· Responsible for drafting, authoring, reviewing, and submitting key regulatory documents including Investigational Medicinal Product Dossier (IMPD), CMC sections of Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), U.S. Food and Drug Administration (FDA) briefing books/documents, Marketing Authorization Applications (MAAs), and other documents as needed.\n· Work with both internal and external stakeholders to support inspection readiness and preparedness at both DBV and all CDMOs, and other contract testing facilities.\n· Hybrid Role: Work from Warren, NJ office 3 days a week / 2 days from home. Additional days in the office as needed.\n· Regular international Travel required - 15% of time\nVeeva RIM experience is a must\nLocation: Warren, New Jersey - minimum 3 days on site\nSalary Range : $190-230k\nKey Responsibilities : \nPrepare Module 3s of BLAs and MAAs for drug/device (patch) combination products for food allergies including peanut allergy, celiac disease, and eosinophilic esophagitis plus prepare the CMC sections of INDs and IMPDs for early-stage products\nDevelop and coordinate CMC submissions to regulatory authorities, monitor progress, and coordinate written and verbal (during meeting) responses.\nReview CMC-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development.\nContribute to the implementation of regulatory processes and procedures, including developing and authoring internal work instructions and company SOPs.\nMonitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities.\n\nQualifications : \nBachelor’s degree in life sciences or equivalent discipline is required; Advanced degree (MS, PhD, PharmD) preferred. US RAC and PMP certification a plus.\n\nMinimum of 10-years’ experience working in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents (e.g. FDA briefing books, IMPD, IND, BLA, NDA), and directly interfacing with health authorities (i.e. FDA, EMA).\n\nCritical ability to work closely with in-house Subject Matter Experts (SMEs) and Contract Manufacturing Organizations (CMOs) to acquire critical information in support of preparing the various segments of Module 3 and responses to Health Authority questions and issues\n\nMajor capability to set, monitor and meet CMC Module 3 and other Regulatory CMC timelines and deadlines\n\nExperience in working with CMC Regulatory formats and templates for eCTD compilation of information and data displays\n\nPrior experience participating in and writing documents for the FDA and other Health Authorities required.\n\nDirect experience developing early and late-phase programs for combination products, biologics, and/or innovative technologies.\n\nDirect experience participating in cross-functional teams in a matrix environment.\n\nExperience working in both large pharmaceutical and small biotechnology organizations.\n\nExperience providing strategic regulatory CMC guidance to drug development, registration, and post-market support teams.\n\nBroad familiarization and current, working knowledge of GxP (i.e., GMP, GDP, GCP).\n\nUnderstanding and working experience with biological products, combination products, and innovative products in early and late-phase clinical development\n\nStrong verbal communication skills with the ability to articulate CMC/regulatory concepts across line functions and to external audiences is required.\n\nAbility to write regulatory high-quality documents (e.g., Briefing documents, IND amendments, IMPD, and other regulatory documents, etc.) is required.\n\nExperience with external and internal stakeholders to support global scientific and business strategies.\n\nDemonstrated working knowledge and experience of US, EU, and international regulatory requirements pertinent to this role.\n\nExercise critical thinking, solution-oriented problem solving, strategic thinking skills with ability to impact and influence in a matrix environment and across functions.\n\nStrong analytical and business communication skills.\n\nKnowledge of French language is a strong plus\n\nVeeva RIM experience is a must\n\n Behavioral skills : \nCuriosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,\n\nCourage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,\n\nCollaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,\n\nCredibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.","description_format":"text","description_chars":5369,"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":[{"language":"French","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-12T22:22:34Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":19,"expected_fill_days":147,"reasons":["conf:0","win:early"],"computed_at":"2026-11-01T06:10:25Z"},"pay":{"stated_usd_annual":230000,"is_top_pay":false},"html_url":"https://alion.io/job/dbv-technologies-director-regulatory-affairs-cmc","json_url":"https://alion.io/job/dbv-technologies-director-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-11-01T06:25:36Z","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":9980,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":1941434},"rest":"https://alion.io/mcp/rest/get_company?id=1941434"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdbv-technologies-director-regulatory-affairs-cmc"},{"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%2Fdbv-technologies-director-regulatory-affairs-cmc"},{"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%2Fdbv-technologies-director-regulatory-affairs-cmc"},{"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/dbv-technologies-director-regulatory-affairs-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdbv-technologies-director-regulatory-affairs-cmc"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2395084}},{"tool":"search_jobs","arguments":{"company":"dbv-technologies.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2395084},"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. 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