Associate Director, Regulatory Affairs (Oncology ...

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with a strong presence in the U.S., dedicated to meeting patient needs in oncology, urology, women's health, rare diseases, and various therapeutic fields. We are committed to accelerating research and development to bring innovative therapies to patients sooner. Join our Team We are seeking a talented and driven professional to take on the role of Associate Director, Regulatory Affairs (Oncology Products). In this pivotal position, you will be part of our Global Regulatory Affairs (GRA) team and primarily act as a Regional Regulatory Leader (RRL) or Global Regulatory Leader (GRL) for specific products. You will be at the forefront of regulatory submissions and communications with health authorities, shaping the future of our oncology portfolio. Key Responsibilities Lead and manage regional regulatory activities for the United States, Europe, and other regions as part of a dynamic Global Regulatory Team (GRT). Develop and steer regulatory strategies in alignment with global registration objectives for your assigned projects. Collaborate closely with the global regulatory lead and CMC regulatory lead to shape effective regulatory interactions with health authorities. Document and communicate key decisions and outcomes from regulatory authority engagements. Coordinate efforts across project teams to create effective regulatory submission strategies. Prepare and oversee the submission process, partnering closely with Regulatory Operations to ensure timely electronic submissions. Guarantee compliance with global regulatory standards and internal policies, and lead global regulatory compliance initiatives. Regularly update Global Regulatory Teams, project teams, and relevant governance boards on progress and developments. Foster professional relationships within the organization to encourage collaborative efforts and knowledge sharing. Review and contribute to scientific documentation including nonclinical, clinical, and CMC data as necessary. Advise team members on potential regulatory challenges, offering solutions and strategic responses. Ensure the quality and rigor of all submissions to health authorities, upholding the standards of our organization. Participate in regional health authority meetings and assist in briefing document preparations. Contribute to the development of a comprehensive global regulatory functional plan through research and analysis of current regulatory guidelines. Help create and review Standard Operating Procedures (SOPs) and operational frameworks for the regulatory department. Core Competencies Exceptional verbal and written communication skills. Strong ethical standards and professional integrity. Ability to thrive in a diverse, fast-paced environment. Proven adaptability in a matrix organization and managing changing priorities. Effective decision-making skills with a focus on achieving results. Solid understanding of medical terminology and relevant FDA and ICH regulations. Experience in evaluating and contributing to scientific documentation across clinical phases. Highly analytical with the capacity to discern key issues and identify potential solutions. Proficient in developing successful regulatory strategies and documentation. Confidence in presenting to various organizational levels, including senior management. Qualifications Bachelor's degree in a scientific field is required, with at least 7 years of experience in the biopharmaceutical or pharmaceutical industry. A minimum of 4 years specifically in regulatory affairs is preferred. Experience in oncology product development is a significant advantage. Familiarity with electronic regulatory submissions and regulatory templates. Knowledge of EU Clinical Trial Regulations and regulatory requirements in global markets is desirable. The base salary range for this role is between $156,000 and $195,000. This salary is part of a comprehensive rewards package that includes merit-based increases, participation in incentive plans, retirement benefits, and various insurances, as well as generous paid time off policies. Compensation will be tailored to individual experience, skills, and qualifications. Commitment to Diversity: Sumitomo Pharma America embraces diversity as a fundamental value and is committed to providing equal employment opportunities to all qualified candidates.

Created: 2026-03-10