{"id":2995503,"url":"https://alion.io/job/nuvation-bio-director-regulatory-cmc","title":"Director, Regulatory CMC","company":{"id":3792624,"name":"NUVATION BIO","domain":"nuvationbio.com","url":"https://alion.io/company/nuvationbio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JobScore","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":171000,"max_usd":293000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":100},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-16T17:38:55Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-05T08:03:03Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"Who we are…\nNuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.\nWhat you’ll be doing\nThe Director of Regulatory CMC is responsible for leading the strategic development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across the company portfolio from early-stage discovery through all clinical phases to product registration and post-approval commercialization, as applicable. The primary focus is on managing clinical trial applications, marketing authorizations, and ensuring absolute compliance with global health authority regulations for both drug substance and drug product. This role also serves as the critical regulatory liaison to bridge technical operations, quality assurance, and clinical development findings into compliant, high-quality, and inspection-ready global regulatory submissions.\nYou will be responsible for…\nLead thedevelopment, execution, and lifecycle management of global Regulatory CMC\nstrategies for clinical-stage and commercial products.\n\nLead, author,review, and critically assess CMC regulatory documents and technical reports to\nensure accuracy, consistency, scientific rigor, and suitability for global\nregulatory filings.\n\nProvidestrategic Regulatory CMC leadership and guidance to process chemistry,\nformulation development, analytical, quality, manufacturing, clinical, supply\nchain, and commercial teams to ensure development and lifecycle activities are\naligned with global regulatory expectations.\n\nOverseeplanning, preparation, and delivery of high-quality CMC sections for INDs,\nCTAs, IMPDs, NDAs/MAAs, amendments, supplements, variations, annual reports,\nand responses to health authority questions.\n\nEvaluatecomplex CMC changes, including manufacturing process, analytical method,\nspecification, stability, packaging, supplier, and manufacturing site changes,\nand define appropriate global regulatory reporting and submission strategies.\n\nLeadRegulatory CMC gap assessments of source documents, development reports,\nmanufacturing records, validation packages, specifications, stability data, and\nquality documents to identify filing risks, compliance gaps, and remediation\nplans.\n\nDirect andcoordinate interactions with CMOs, CDMOs, contract laboratories, consultants,\nand internal functions to obtain, review, and finalize CMC documentation\nrequired for regulatory submissions, commitments, and lifecycle management\nactivities.\n\nProvidein-depth Regulatory CMC review of manufacturing, analytical, stability,\nvalidation, and quality information to support development programs and global\nregulatory submissions.\n\nLeadCMC-related interactions with regulatory authorities, including preparation of\nbriefing materials, meeting packages, information request responses, written\ncommitments, and strategic negotiation positions.\n\nEnsure CMCsubmission content is complete, consistent, scientifically justified, and\ncompliant with applicable ICH, FDA, EMA, NMPA, MFDS, and other global health\nauthority expectations.\n\nDrivecross-functional alignment with Regulatory Affairs, Quality, Technical\nOperations, Supply Chain, Clinical, Commercial, and Program Management teams to\nidentify CMC regulatory risks, develop mitigation plans, and achieve submission\ndeliverables and timelines.\n\nManage andprovide oversight of Regulatory CMC contributions from external consultants and\nsubject matter experts to support regulatory strategy, submission planning,\nauthoring, health authority responses, inspections, audits, due diligence, and\nproduct lifecycle activities.\n\nMonitorglobal Regulatory CMC trends, guidance updates, and precedents to inform\nregulatory strategy, risk assessments, and continuous improvement of submission\nquality and compliance.\n\nRepresentRegulatory CMC in inspections, audits, due diligence activities, governance\ndiscussions, and cross-functional decision-making forums, as required.\n\nWhat Knowledge & Experience you'll bring to us...\nAdvanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related discipline with generally 10+ years of pharmaceutical industry experience, including substantial experience in Regulatory CMC and increasing responsibility for global regulatory strategy.\nDemonstrated ability to lead preparation, review, and delivery of CMC content for global regulatory submissions across clinical development, marketing application, post-approval, and lifecycle management stages.\nStrong experience with small molecule drug development and commercialization, including clinical trial applications, marketing applications, post-approval changes, manufacturing site transfers, supplier changes, stability strategies, and product lifecycle management activities.\nExpert understanding of global Regulatory CMC requirements, including ICH guidelines, cGMP expectations, compendial standards, and FDA, EMA, NMPA, MFDS, and other health authority requirements and expectations.\nProven ability to interpret complex technical CMC information, assess regulatory impact, and translate data into clear, scientifically sound, and regulatory-appropriate submission content, briefing materials, justifications, and health authority responses.\nExcellent written and verbal communication skills, with a demonstrated ability to influence, advise, and collaborate effectively with cross-functional teams, senior leadership, external partners, and regulatory authorities.\nDemonstrated ability to provide oversight of external consultants, CMOs, CDMOs, and contract laboratories to ensure timely delivery of high-quality CMC information in support of regulatory submissions, health authority commitments, and business objectives.\nAdvanced proficiency in authoring and reviewing Module 3/CMC sections, briefing documents, responses to information requests, annual reports, supplements, variations, and other regulatory submission documents.\nHighly organized, self-motivated, and capable of leading multiple products, projects, timelines, regulatory deliverables, and cross-functional priorities in a fast-paced environment.\nBehavioral skills to be successful...\nProblem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.\nPersonable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.\nCredible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.\nEmotional intelligence, curiosity, and a knack to figure out a way to build something better\nCommunication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.\nAccountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.\nAdaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.\nWhat we have for you!\nCompetitive Base Salary, Bonus, and Equity Plans\nUnlimited Vacation and 10 Sick Days Annually\nExcellent Medical, Dental, and Vision Coverage\n401K with Company Matching\nand much more!\nThe base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.\nDisclaimer\nNuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.\nThis job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time. \n Note to all external Recruiters & Staffing Agencies\nAll of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.","description_format":"text","description_chars":9589,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T10:57:14Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 8","filings_12m":8,"filings_prev_12m":5,"green_card_filings_12m":0,"median_offered_wage_usd":172500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":47,"band":"ok","label":"Likely open","p_open":1,"p_active":0.86,"p_room":0.55,"age_days":49,"expected_fill_days":41,"reasons":["conf:2","win:tail"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/nuvation-bio-director-regulatory-cmc","json_url":"https://alion.io/job/nuvation-bio-director-regulatory-cmc.json","meta":{"generated_at":"2026-11-05T12:18:33Z","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":15920,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":3792624},"rest":"https://alion.io/mcp/rest/get_company?id=3792624"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnuvation-bio-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%2Fnuvation-bio-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%2Fnuvation-bio-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/nuvation-bio-director-regulatory-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnuvation-bio-director-regulatory-cmc"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2995503}},{"tool":"search_jobs","arguments":{"company":"nuvationbio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2995503},"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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