Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with a strong presence in the U.S., focused on addressing patient needs across multiple therapeutic areas including oncology, urology, women's health, and rare diseases. Join us in our mission to accelerate research and development, bringing innovative therapies to patients sooner.

Join Our Dynamic Team

We are looking for a passionate and skilled professional to fill the important role of Associate Director, Regulatory Affairs for Oncology Products. In this key position, you will be part of our Global Regulatory Affairs (GRA) team, serving as a Regional Regulatory Leader (RRL) or Global Regulatory Leader (GRL) for specific oncology products. You will play a pivotal role in managing regulatory submissions and engagements with health authorities, influencing the future of our oncology portfolio.

Key Responsibilities

• Lead regional regulatory initiatives for the United States, Europe, and other markets as part of our collaborative Global Regulatory Team (GRT).
• Formulate and execute regulatory strategies aligned with global registration goals for assigned projects.
• Work closely with global and CMC regulatory leads to facilitate productive regulatory interactions with health authorities.
• Document and communicate crucial decisions and outcomes from interactions with regulatory bodies.
• Coordinate efforts across project teams to devise and implement effective regulatory submission strategies.
• Oversee the submission process, collaborating with Regulatory Operations to ensure timely electronic submissions.
• Ensure all activities comply with global regulatory standards and internal policies while leading compliance initiatives.
• Regularly update Global Regulatory Teams, project teams, and governance boards on project progress and updates.
• Nurture professional relationships within the organization to promote collaboration and knowledge sharing.
• Review and contribute to scientific documentation, including nonclinical, clinical, and CMC data.
• Provide advice on regulatory challenges, proposing solutions and strategic responses.
• Maintain the quality and rigor of all submissions to health authorities, adhering to organizational standards.
• Participate in health authority meetings and assist in preparing briefing documents.
• Contribute to the development of a robust global regulatory functional plan through analysis of current regulatory guidelines.
• Assist in creating and reviewing Standard Operating Procedures (SOPs) and regulatory operational frameworks.

Core Competencies

• Excellent verbal and written communication skills.
• Strong ethical standards and a commitment to professional integrity.
• Ability to excel in a diverse, fast-paced environment.
• Proven adaptability in a matrix organization and managing shifting priorities.
• Effective decision-making skills focused on achieving results.
• Strong 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 ability to identify key issues and propose effective solutions.
• Skilled in developing successful regulatory strategies and documentation.
• Confidence in presenting to various levels of the organization, including senior management.

Qualifications

• Bachelor's degree in a scientific field is required, with 7 years of experience in the biopharmaceutical or pharmaceutical industry.
• A minimum of 4 years in regulatory affairs is preferred.
• Experience with oncology product development is highly desirable.
• Familiarity with electronic regulatory submissions and templates is beneficial.
• Knowledge of EU Clinical Trial Regulations and global regulatory requirements is a plus.

The base salary for this position ranges from $156,000 to $195,000, complemented by a comprehensive rewards package, including merit-based increases, participation in incentive plans, retirement benefits, various insurance options, and generous paid time off. Compensation will be tailored to the individual's experience, skills, and qualifications.

Commitment to Diversity:
Sumitomo Pharma America values diversity and is committed to providing equal employment opportunities to all qualified candidates.

Estimated Salary: $20 to $28 per hour based on qualifications.