{"id":3184090,"url":"https://alion.io/job/argenx-associate-director-regulatory-cmc-development","title":"Associate Director Regulatory CMC – Development","company":{"id":1805561,"name":"argenx","domain":"argenx.com","url":"https://alion.io/company/argenx","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":12,"ghost_share":0,"stale_share":0.833,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ghent, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":137500,"currency":"EUR","period":"year","gross":null,"usd_annual":154051},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-17T00:00:00Z","employer_posted_date":"2026-08-17","last_verified_at":"2026-10-28T11:35:23Z","board_verified":true,"closed_at":null,"days_open":72,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":72},"description":"Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.\nWe are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.\nPURPOSE OF THE FUNCTION\nResponsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include developing and implementing regulatory strategies, authoring / reviewing of quality submission packages, ensuring their accuracy and timely delivery, and coordinating responses to health authorities for the company’s large molecule therapeutic drug candidates throughout their clinical development towards marketing approval as well as global life cycle management projects. Additionally, the job requires strong communication and coordination with external partners, contributing to risk assessments and mitigation strategies. In this role you will have a front seat in the heart of a development/commercial organization and able to weigh into CMC development strategies.\nDemonstrates strong leadership, effective cross-functional collaboration, and excellent communication skills.\nREPORTING LINE\nHead of Global Regulatory CMC\nROLES AND RESPONSIBILITIES\nDevelop, plan and execute appropriate regulatory strategies of pre-clinical, clinical, and commercial stage programs in close collaboration with the regulatory sub-functions, quality and CMC team members.\nResponsible for preparing and managing CMC regulatory submission plans (including IND/IMPD/CTAs/MAAs), ensuring submissions are accurate, complete, and timely in accordance with regulations and procedures,\nCoordinate, write and review responses to regional and global Health Authorities to ensure timely submission.\nParticipate to the authoring and preparing IND, IMPD, scientific briefing documents, Investigator Brochures and regulatory agency response documents for therapeutic compounds in development in close collaboration with external and internal stakeholders.\nParticipate to the authoring and preparing BLA, J-MAA, MAA and ROW applications (module 2 and 3) and related life cycle documents.\nCoordinating activities with external partners ensuring that deliverables are executed with the right priorities and to the required standards and maintain open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions.\nProviding strategic input into CMC risks assessment and mitigation plans and ensuring they remain in line with the overall global Regulatory CMC strategy.\nConduct regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases.\nTracking execution of regulatory commitments.\nSKILLS AND COMPETENCIES\nTeam player; able to build effective relationships with internal and external stakeholders.\nLeadership and communication skills\nExperience in operations, planning, project management, and tracking projects with high complexity and risk, including clearly defined critical paths.\nExperience managing projects across global locations and time zones, as well as working effectively in diverse cultural and international environments.\nWell organized and able to handle multiple assignments in parallel.\nExcellent writing skills coupled with comprehensive knowledge of pharmacopoeial requirements, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements;\nProficiency with MS-Word and preferably with document management systems.\nEye for detail and quality conscious attitude.\nProactive - can do mentality.\nFluent in English - our working language.\nEDUCATION, EXPERIENCE AND QUALIFICATIONS\nMaster’s degree or PhD in biotechnology, pharmaceutical sciences or bioengineering, with relevant expertise in CMC development and CMC regulatory dossier development (IND/IMPD/BLA/MAA).\nScience oriented, experience with large molecules is a plus. #LI-Onsite\n\nThe annual base salary hiring range for this position is €100,000.00 - €137,500.00 EUR\n\nThis job is eligible to participate in our short-term and long-term incentives program.\nThe hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.\nAt argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.\nBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at .","description_format":"text","description_chars":6053,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biologics & Biosimilars","Rare Disease Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-23T22:42:05Z"}],"visa":[],"liveness":{"score":12,"band":"cold","label":"Long shot","p_open":1,"p_active":0.437,"p_room":0.28,"age_days":72,"expected_fill_days":28,"reasons":["conf:19","stale_co","win:tail","crowd:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":154051,"is_top_pay":false},"html_url":"https://alion.io/job/argenx-associate-director-regulatory-cmc-development","json_url":"https://alion.io/job/argenx-associate-director-regulatory-cmc-development.json","meta":{"generated_at":"2026-10-28T17:55:04Z","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":24477,"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":1805561},"rest":"https://alion.io/mcp/rest/get_company?id=1805561"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fargenx-associate-director-regulatory-cmc-development"},{"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%2Fargenx-associate-director-regulatory-cmc-development"},{"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%2Fargenx-associate-director-regulatory-cmc-development"},{"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/argenx-associate-director-regulatory-cmc-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fargenx-associate-director-regulatory-cmc-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3184090}},{"tool":"search_jobs","arguments":{"company":"argenx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3184090},"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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