VP, Regulatory Affairs R&D Biopharma

OverviewSumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada and Europe, focused on oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company has marketed products and a diverse pipeline of early- to late-stage assets, aiming to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or LinkedIn profile.Job OverviewWe are currently seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads Regulatory Affairs for biopharma R&D and reports to the Chief Development Officer for biopharma R&D. Responsible for providing leadership on regulatory strategies for earliest possible approvals for the assets under Biopharma R&D. Focus of Biopharma R&D includes Gemtesa, Myfembree, Rethymic, regenerative medicines, and CNS assets.Job Duties and ResponsibilitiesRegulatory StrategyDevelop and Manage Regulatory Affairs StrategyDevelop and gain approval for regulatory strategy to meet the Company’s objectivesOversee the execution of the most effective product registration pathways to bring products to market in a cost-effective and highly compliant mannerCollaboratively ensure that regulatory strategies are aligned to the SMP group business strategyCollaborate with Head of RA at SMP appropriatelyProvide oversight on evaluation and analysis of trends pertaining to government regulatory activities on a global basis and anticipate impacts that changing regulations will have on the Company’s product portfolioServe as the resident senior expert on all regulatory matters with key external stakeholders, internal steering/review committees, business partners, and government entities on a global basisRecommend and facilitate decision making on all Regulatory matters in close partnership with the Chief Development Officer and other key stakeholdersEstablish key business metrics with market reference points to gauge RA productivity and efficiencyDevelop, present and manage RA budget and resource plan in close partnership with regional operating centers, corporate planning and other appropriate functional groupsResponsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget processServe as the senior point of contact for internal communicationsEnsure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirementsEstablish strong education/awareness of regulatory requirements cross-functionally through comprehensive education initiativesOversees Regulatory operations and medical writing team as appropriatePerform other duties as directedManage and Develop TalentInspire and lead RA staff to ensure attainment of established goals and objectivesEnsure global compliance with all relevant internal and external policies and regulations applicable to drug development and regulatory approvalPromote a high performance – results oriented collaborative work cultureEstablish clear expectations, and monitor delivery of excellent performanceEstablish resource plan to ensure that RA strategy and operational plans are appropriately resourced to support the Company’s business imperativesPromote work environment that includes employee development, accountability, proactive feedback and high performance standardsRegulatory Best PracticesPromote and integrate industry best practices that fit well with the Company’s operating culturePromote a highly interconnected RA operating cultureEstablish and oversee compliance to global SOPs and work practices governing all phases of the regulatory processEnsure that regulatory pathways are developed to deliver well planned registration roadmap with full understanding of the risks and opportunitiesDevelop and manage the regulatory affairs budget with a focus on cost-effectiveness, efficiency and maintenance of qualityCommunicationsAccurate and timely reporting status regulatory projects; escalate unresolved issues to appropriate executive leadershipSteward communications with regulatory agencies to ensure favorable registration outcomeBuild and Maintain Key RelationshipsDevelop highly collaborative and responsive relationships with key stakeholdersRepresent R&D decision committees defined as company rulesBusiness DevelopmentSupport Business Development and New Product Planning and assessment activities specifically related to regulatory analysis and due diligence. Also support regulatory filings and joint committee membership with strategic partnersLocation and TravelCandidate local to Marlborough, MA is preferred, not required. Primarily remote role with periodic on-site meetings in office.Must be able to travel domestically and internationally as needed.Key Core CompetenciesHighly developed industry and regulatory acumen with the ability to formulate strategies and operational plans that address the interests of the CompanyHighly developed understanding of global regulatory dynamicsUnquestionable ethics, professional integrity, and personal values consistent with the SMPA valuesDemonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through continual communication of group mission and team-based outcomesAbility to provide motivational leadership to help the global regulatory organization understand the company’s strategy and futureAbility to shape and implement and sustain change efforts and instill a culture of accountability and nimblenessFast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessaryRequires a high level of initiative and independenceExcellent written and oral communication skills requiredEducation and ExperienceDoctoral degree (MD, Pharm.D. or Ph.D.) with 20+ years of relevant experience in biotech or pharmaceutical industry with at least 10 years of executive management level experience within Regulatory AffairsDemonstrated regulatory leadership of early phase to late phase compoundsExperience with CBER not only CDERSignificant international experience working in multicultural and multi-regional environments is requiredThe base salary range for this role is $280,560 to $350,700. Base 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.Disclaimer: 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.Equal Employment Opportunity: Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital status; sex, gender identity or expression; disability; veteran or military status; or any other characteristic protected by law. #J-18808-Ljbffr

Created: 2025-10-06