Sumitomo Pharma America, Inc.

Compliance

• We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief Development Officer for biopharma R&D. Responsible for providing leadership regulatory strategies for earliest possible approvals for the assets under Biopharma R&D. Focus of Biopharma R&D is Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets.
• Regulatory Strategy Develop and Manage Regulatory Affairs Strategy: Develop and gain approval for regulatory strategy to meet the Company’s objectives. Oversee the execution of the most effective product registration pathways to bring products to market in a cost-effective and highly compliant manner Collaboratively ensure that regulatory strategies are aligned to the SMP group business strategy Collaborate with Head of RA at SMP appropriately Provide 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 portfolio. Serve 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 basis Recommend and facilitate decision making on all Regulatory matters in close partnership with the Chief Development Officer and other key stakeholders Establish key business metrics with market reference points to gauge RA productivity and efficiency Develop, present and manage RA budget and resource plan in close partnership with regional operating centers, the corporate planning and other appropriate functional groups Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process Serve as the senior point of contact for internal communication Ensure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements Establish strong education/awareness of regulatory requirements cross functionally through comprehensive education initiatives Oversees Regulatory operation and medical writhing team as appropriately Perform other duties as directed.
• Manage and Develop Talent Inspire and lead RA staff to ensure attainment of established goals and objectives Ensure global compliance with all relevant internal and external policies and regulations applicable to drug development and regulatory approval Promote a high performance –results oriented collaborative work culture Establish clear expectations, and monitor delivery of excellent performance Establish resource plan to ensure that RA strategy and operational plans are appropriately resourced to support the Company’s business imperatives Promote work environment that includes employee development, accountability, proactive feedback and high performance standards.
• Regulatory Best Practices Promote and integrate industry best practices that fit well with the Company’s operating culture Promote a highly interconnected RA operating culture Establish and oversee compliance to global SOPs and work practices governing all phases of the regulatory process Ensure that regulatory pathways are developed to deliver well planned registration roadmap with full understanding of the risks and opportunities Develop and manage the regulatory affairs budget with a focus on cost-effectiveness, efficiency and maintenance of quality Communications Accurate and timely reporting status regulatory projects; escalate unresolved issues to appropriate executive leadership Steward communications with regulatory agencies to ensure favorable registration outcome Build and Maintain Key Relationships Develop highly collaborative and responsive relationships with key stakeholders Represent R&D decision committees defined as company rules Business Development Support 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 partners.

VP, Regulatory Affairs – R&D, Biopharma

Project Manager

• Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
• Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
• Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
• Provides oversight and management of CROs, consultants and vendors.
• Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
• Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
• Monitors the status of clinical data collection of assigned clinical trials.
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
• Prepares and reviews study-related documents when required.
• Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
• Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
• Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
• Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
• Ensures assigned studies adhere to all applicable regulations and requirements.
• Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
• Evaluate CRO and vendor performance and support the improvement initiatives.
• Participate in the preparation, review, updating and training of SOPs.
• Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
• May Mentor other team members.
• Perform other duties as requested by the senior management.

Senior Manager, Clinical Project Management

Insurance

• Manage global cash operational activities & forecasting.
• Manage bank and broker relationships.
• Oversee and manage treasury operations including cash management, banking structure, and funding operations.
• Oversee cash forecasting short-term and long-term cash forecasting using both direct and indirect methodologies.
• Support funding needs and excess cash flow understanding.
• Develop (in conjunction with VP) and execute Treasury strategy to reduce working capital globally across group entities to reduce excess cash levels.
• Direct corporate insurance programs in alignment with business risk profile.
• Manage Banker & Broker relationships.
• Oversee & manage cash pooling across SMPA group entities and parent entity in Japan.
• Design, research, recommend, and implement treasury systems to support operations.
• Manage short and long-term debt arrangements.
• Support and utilize inter-company payments & arrangements to optimize cash flow between entities while maintaining compliance and Tax strategy.
• Develop and support two direct reports.

Director, Treasury and Corporate Insurance

Procurement

• Drive value by partnering with stakeholders across departments to deliver source-to-contract activities for R&D services
• Negotiate and contract with supply base and ensure alignment with category strategies and business plans
• Deliver strategic sourcing, contract management, supplier market intelligence, financial productivity, supplier performance management, and risk mitigation
• Develop and execute Sourcing Category Plans; negotiate and redline service contracts and statements of work
• Lead end-to-end competitive sourcing activities (RFx), generate sourcing insights using spend analytics and benchmarking
• Maintain sourcing practices in accordance with corporate ethics, financial policy, and internal control requirements
• Pursue ongoing development of relevant skills and lead change management to improve productivity and efficiency

Manager, Strategic Sourcing, R&D

Customer Success Manager

• Define and execute the Veeva CRM roadmap aligned with commercial and medical strategies.
• Establish governance processes to ensure data quality, compliance (e.g. PDRP, GDPR, CCPA), and system integrity.
• Serve as the primary business owner of Veeva CRM, ensuring alignment with commercial goals.
• Lead the configuration design, deployment, and continuous improvement of Veeva CRM modules (e.g., Veeva CRM, CLM, Approved Email, Engage).
• Collaborate with Commercial IT and third-party vendors to manage system enhancements, integrations (e.g., MDM, data warehouses), and issue resolution.
• Ensure seamless integration with other commercial platforms (e.g., Veeva Vault, Salesforce Marketing Cloud, BI tools).
• Partner with Sales, Marketing, and Field Medical teams to translate business needs into CRM functionality.
• Support territory alignment, call planning, and multichannel engagement strategies.
• Monitor and improve field adoption through training, feedback loops, and change management.
• Support development and maintenance of dashboards and KPIs to track field activity, HCP engagement, and CRM utilization.
• Collaborate with Commercial Analytics to generate actionable insights from CRM data, as well as Commercial Reporting to identify metrics for integration in ongoing reporting.
• Drive continuous improvement through data-driven recommendations.
• Direct the Enterprise CRM team by providing guidance and mentorship, while ensuring ample opportunities for learning and that career goals are met
• Act with speed, agility, and accountability, while adapting to evolving business needs
• Cultivate meaningful internal and external partnerships, adding value and insights for the organization
• Key Core Competencies
• Strategic thinking and ability to align CRM capabilities with business goals.
• Keen ability to prioritize competing requests keeping the focus on business priority
• Strong project management and stakeholder engagement skills.
• Excellent communication and cross-functional collaboration.
• Analytical mindset with ability to derive insights from CRM data.
• Deep understanding of pharmaceutical sales models and compliance requirements
• Proven success leading and developing a team

VP, Regulatory Affairs – R&D, Biopharma

Senior Manager, Clinical Project Management

Director, Treasury and Corporate Insurance

Manager, Strategic Sourcing, R&D

Associate Director, Commercial Operations - Enterprise CRM