VP, Regulatory Affairs R&D Biopharma

Sumitomo Pharma Co., Ltd. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. Job Overview Vice President, Regulatory Affairs, Biopharma R&D – responsible for leading regulatory strategy for early‑phase to late‑phase biopharma assets (Gemtesa, Myfembree, Rethymic, regenerative medicines and CNS assets). Reports to the Chief Development Officer for Biopharma R&D. Job Duties and Responsibilities Develop and manage regulatory strategy to meet company objectives. Oversee the execution of product registration pathways to bring products to market cost‑effectively and compliant. Align regulatory strategies with the SMP group business strategy. Collaborate with the Head of RA at SMP and other key stakeholders. Provide oversight of global regulatory activities and anticipate impacts of changing regulations. Serve as the resident senior expert on regulatory matters with external stakeholders, internal committees, and government entities worldwide. Recommend and facilitate decision making on all regulatory matters in partnership with the Chief Development Officer. Establish key business metrics to gauge RA productivity and efficiency. Develop, present, and manage RA budget and resource plan in partnership with regional centers, corporate planning, and functional groups. Provide global guidance and monitor global regulatory line items in the clinical development budget process. Lead internal communications for regulatory matters. Ensure launch materials and new claims development with Marketing, Medical, and Legal are guided by regulatory requirements. Establish strong cross‑functional education initiatives on regulatory requirements. Oversee the regulatory operation and medical writing team as appropriate. Perform other duties as directed. Manage and Develop Talent Inspire and lead RA staff to achieve established goals and objectives. Ensure global compliance with all 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. Resourcing: establish resource plan to support RA strategy and operational plans. Promote a 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. Develop regulatory pathways to deliver a well‑planned registration roadmap with full understanding of risks and opportunities. Manage the regulatory affairs budget with focus on cost‑effectiveness, efficiency and quality. Communications Accurate and timely reporting of regulatory project status; expedite unresolved issues to executive leadership. Steward communications with regulatory agencies to ensure favorable registration outcomes. Build and Maintain Key Relationships Develop highly collaborative and responsive relationships with key stakeholders. Represent R&D decision committees as defined by company rules. Business Development Support business development and new product planning, with regulatory analysis and due diligence. Also support regulatory filings and joint committee membership with strategic partners. Location and Travel Candidate local to the Marlborough, MA is preferred but not required. Primarily remote role with periodic on‑site meetings in office. Must be able to travel domestically and internationally as needed. Key Core Competencies Highly developed industry and regulatory acumen to formulate strategies and operational plans that address company interests. Deep understanding of global regulatory dynamics. Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values. Demonstrated ability to align people, policies, and processes to foster collaboration and sustain it through continual communication. Motivational leadership to help the global regulatory organization understand the company’s strategy and future. Ability to shape, implement, and sustain change efforts and instill a culture of accountability and nimbleness. Fast‑paced environment handling multiple demands; must exercise appropriate judgment. High level of initiative and independence. Excellent written and oral communication skills. Education and Experience Doctoral degree (MD, Pharm.D. or Ph.D.) with 20+ years of relevant experience in biotech or pharmaceutical industry, including at least 10 years of executive management level experience within Regulatory Affairs. Demonstrated regulatory leadership of early‑phase to late‑phase compounds. Experience with CBER (not only CDER). Significant international experience working in multicultural and multi‑regional environments. Compensation The base salary range is $280,560 to $350,700, part of a total rewards package that includes merit‑based salary increases, short incentive plan participation, eligibility for a 401(k) plan, medical, dental, vision, life and disability insurance, and generous paid time off. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Equal Employment Opportunity Sumitomo Pharma America is an Equal Employment Opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, domestic partnership, gender, sexual orientation, disability, veteran or military status or any other characteristic protected by law. #J-18808-Ljbffr