{"id":2663402,"url":"https://alion.io/job/sumitomo-pharma-director-regulatory-affairs","title":"Director, Regulatory Affairs","company":{"id":1797163,"name":"Sumitomo Pharma","domain":"sumitomo-pharma.com","url":"https://alion.io/company/sumitomo-pharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Marlborough, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":195900,"max":244900,"currency":"USD","period":"year","gross":null,"usd_annual":244900},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-06T00:00:00Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-11-04T19:15:42Z","board_verified":true,"closed_at":null,"days_open":30,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":30},"description":"Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.\nJob Overview:\nThis position reports to Executive Director, Regulatory Affairs and is part of the Biopharma R&D Regulatory Affairs organization based in the US. The role is responsible for serving as the Global Regulatory Leader (GRL) and/or Regional Regulatory Leader (RRL) for assigned projects and works closely with cross-functional teams to ensure effective collaboration and alignment.\nThis position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the CNS portfolio of the company. This position may train/mentor junior staff.\nThis position works with a high level of autonomy and requires limited coaching and mentoring.\nEssential Functions Required for Job:\nLeads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy of the product\nAs a Regional Regulatory Lead, if applicable, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)\nCompetently represents RA on project team meetings\nLeads and coordinates project team members in developing regulatory strategy for applicable documents/ activities.\nPlans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations on electronic submissions\nAssesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines\nLeads documentation of regulatory authority interactions including decisions and outcomes\nProvides updates at the Global Regulatory Team meetings and project teams as needed\nCollaborates effectively with regulatory operations leader (ROL)\nMaintains professional working relationship with colleagues, fostering collaboration, and idea sharing\nReviews nonclinical, clinical and CMC documentation (e.g. summary documents, nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed\nAdvises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy\nLeads and coordinates local project team members in developing strategy for applicable documents/activities\nEnsures the quality and content of all submissions to Health Authorities\nLeads the regional health authority meetings, liaison with local Health Authority\nDocument owner of briefing book documentation to Health Authorities\nAssist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling\nAccountable in conjunction with the GRL, if applicable, for developing and maintaining the development core data sheet (DCDS) and company core data sheet (CCDS) if required\nEnsure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level\nProvide strategic review of dossier summaries, expert statements, and development management plans\nProvide updates to the GRT, project teams, and governance boards as needed\nLeads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions\nMay be responsible for creating and reviewing SOPs and regulatory department operating procedures.\nKnowledge, Skills and Abilities (general & technical):\nStrong verbal and written communication skills; interpersonal skills; listening skills; organizational skills; and attention to detail required\nUnquestionable ethics, professional integrity, and personal values consistent with the SMPA values \nAbility to work in a diverse environment\nDemonstrated ability to adapt to changing priorities and work effectively in a matrix organization\nDemonstrated ability to facilitate appropriate team decisions\nSense of urgency and perseverance to achieve results\nExperience contributing to electronic regulatory submissions and working with regulatory templates\nAdvanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry\nExperience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed\nUnderstands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution\nProven success/major involvement in pre-IND/IND/NDA/MAA/CTD submissions and approval\nCapable of effectively negotiating with others while maintaining composure\nDevelopment and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document\nExperience in CNS development and ability to learn new therapeutic areas when necessary\nPrior history with post-marketing/brand optimization strategies and commercial awareness\nExperience interacting with the FDA and ex-US Health Authorities\nExperience in successfully leading teams and providing leadership in Health Authority negotiations and meetings\nAbility to make complex decisions and willingness to defend difficult positions.\nComfortable presenting to all levels of the organization including Senior Management.\nHigh degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.\nEducation & Experience Requirements:\nBachelor’s degree in a related field required.\nMinimum 10 years of relevant experience in biotech or pharmaceutical industry\nMaster’s degree required (preferably in a scientific discipline)\nTravel Requirements:\nPrimarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.\nMental/Physical Requirements:\nFast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.\nPeople Management:\nThis is an individual contributor role and does not have direct reports or formal people-management responsibilities.\nTravel Requirements:\nPrimarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.\nMental/Physical Requirements:\nFast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.\nThe base salary range for this role is\n$195,900.00 - $244,900.00Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.\nDisclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.\nConfidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.\nCompliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the \"best\" industry practices and the highest ethical standards.\nIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.\nDrug Screening Requirements\nApplicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.\nSumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer\nQualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nSumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.","description_format":"text","description_chars":10736,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":true,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-16T01:34:25Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 19 · green card filings: 3","filings_12m":19,"filings_prev_12m":5,"green_card_filings_12m":3,"median_offered_wage_usd":166818,"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)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":42,"band":"fade","label":"Fading","p_open":1,"p_active":0.769,"p_room":0.55,"age_days":29,"expected_fill_days":22,"reasons":["conf:1","win:tail"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":244900,"is_top_pay":false},"html_url":"https://alion.io/job/sumitomo-pharma-director-regulatory-affairs","json_url":"https://alion.io/job/sumitomo-pharma-director-regulatory-affairs.json","meta":{"generated_at":"2026-11-05T00:14:16Z","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":237,"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":1797163},"rest":"https://alion.io/mcp/rest/get_company?id=1797163"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsumitomo-pharma-director-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%2Fsumitomo-pharma-director-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%2Fsumitomo-pharma-director-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/sumitomo-pharma-director-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsumitomo-pharma-director-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2663402}},{"tool":"search_jobs","arguments":{"company":"sumitomo-pharma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2663402},"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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