{"id":933199,"url":"https://alion.io/job/calico-director-regulatory-cmc","title":"Director, Regulatory CMC","company":{"id":669150,"name":"Calico","domain":"calicolabs.com","url":"https://alion.io/company/calicolabs","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"C","score":63,"open_postings":21,"ghost_share":0.619,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":275000,"max":280000,"currency":"USD","period":"year","gross":null,"usd_annual":280000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Bioreactors","optional":false},{"name":"GMP","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-02-19T20:01:20Z","employer_posted_date":"2026-08-20","last_verified_at":"2026-10-22T07:53:09Z","board_verified":true,"closed_at":null,"days_open":244,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":244},"description":"Who We Are:\nCalico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.\nPosition Description:\nThe Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical development and ensure seamless commercialization. Acting as a key partner to CMC and Quality, this role is responsible for the CMC content of all investigational and marketing applications, ensuring technical consistency and compliance across all stages of the product lifecycle, from early-stage development through commercialization. This role requires a blend of deep scientific fluency, meticulous attention to detail, and the ability to negotiate effectively with global health authorities. The ideal candidate has a deep understanding of the nuanced differences in regulatory pathways for both small molecules and monoclonal antibodies.\nKey Responsibilities:\nRegulatory Strategy and Agency Interactions\nDesign and implement innovative global CMC regulatory strategies to secure approvals and maintain compliance for clinical and commercial products, identifying potential risks and creating robust mitigation plans\nProvide expert guidance on CMC requirements for both Small Molecules (NCEs) and Biologics (mAbs), including comparability protocols and stability requirements\nAct as the primary CMC point of contact for the FDA, EMA, and other global health authorities\nLead preparations for and represent the company in formal regulatory meetings and in generating responses to Health Authority queries\nAssess the impact of manufacturing changes on global registrations and determine the necessary reporting categories globally\nDefine the necessary data packages to support post-approval supplements\nSubmissions and Document Leadership\nAuthor or direct the preparation, authoring, and technical review of CMC sections for global filings:\n-ND/IMPD: Investigational applications for early-phase trials\n-NDA/BLA/MAA: Marketing applications for US, EU, and other major markets\nManage the lifecycle of the Common Technical Document (CTD) specifically focusing on Module 3 (Quality) and Module 2.3 (Quality Overall Summary)\nCross-Functional Partnership\nCollaborate closely with Process Development, Analytical Development, and Quality Assurance to ensure data integrity and filing readiness\nProvide regulatory risk assessments for various manufacturing scenarios (e.g., changing CDMO sites or scaling up bioreactors)\nMonitor and stay current on the evolving CMC regulations (ICH guidelines, FDA/EMA guidance) and translate complex requirements into actionable internal plans\nPosition Requirements:\nB.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); A Ph.D. or PharmD is highly preferred\n10+ years of experience in the biopharmaceutical industry, with at least 7 years focused specifically on CMC Regulatory Affairs\nSuccessful track record of contributing to least one major marketing application (NDA or BLA) from initial drafting through approval\nStrong understanding of GMP (Good Manufacturing Practices) and ICH guidelines and deep knowledge of small molecule and mAbs modalities\nAbility to interpret complex technical data (e.g., mass spectrometry, impurity profiles, dissolution data) and effectively present it in a clear, regulatory-compliant narrative\nDeep knowledge of FDA, EMA, ICH regulations, and global regulatory requirements\nExceptional communication and interpersonal skills, with the ability to effectively interact and influence internally with cross-functional stakeholders and senior leadership and externally with CMOs and regulatory authorities\nMust be willing to work onsite at least four days per week\nThe estimated base salary range for this role is $275,000 - $280,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.","description_format":"text","description_chars":4504,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Research Institutes"],"lifecycle":[{"event":"open","at":"2026-09-15T12:50:57Z"}],"visa":[],"liveness":{"score":7,"band":"cold","label":"Long shot","p_open":1,"p_active":0.263,"p_room":0.28,"age_days":244,"expected_fill_days":31,"reasons":["conf:1","stale_co","ghost","win:tail","crowd:"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":280000,"is_top_pay":false},"html_url":"https://alion.io/job/calico-director-regulatory-cmc","json_url":"https://alion.io/job/calico-director-regulatory-cmc.json","meta":{"generated_at":"2026-10-22T09:25:59Z","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":6219,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":669150},"rest":"https://alion.io/mcp/rest/get_company?id=669150"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcalico-director-regulatory-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%2Fcalico-director-regulatory-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%2Fcalico-director-regulatory-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/calico-director-regulatory-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcalico-director-regulatory-cmc"}]}