Associate Director, Regulatory Affairs (Oncology)

Sumitomo Pharma America, Inc. • Marlborough, MA

86d • $156,000 - $195,000

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Regulatory Affairs (Oncology). The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring.

Requirements

• Bachelor’s degree in a related field required, preferably in a scientific discipline
• At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience
• Ideally with a minimum of 4 years focused in regulatory affairs
• Oncology product development experience preferred
• Experience contributing to electronic regulatory submissions and working with regulatory templates
• Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials

Responsibilities

• Manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
• Lead regulatory activities for assigned project(s) in line with the global registration strategy of the product
• Support the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs
• Lead and coordinate project team members in developing strategy for applicable documents/activities
• Plan, coordinate, author, and prepare regulatory submissions and work closely with Regulatory Operations in the electronic submission
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes
• Provide updates to the Global Regulatory Team, project teams, and governance boards as needed
• Maintain professional working relationships with colleagues, fostering collaboration and idea sharing
• Review nonclinical, clinical and CMC documentation and contribute to content as needed
• Advise team members of potential regulatory issues and provide possible solutions and mitigation strategy
• Ensure the quality and content of all submissions to Health Authorities
• Contribute to regional health authority meetings, and briefing book documentation to Health Authorities
• Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals
• Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed.

Benefits

• Merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life and disability insurances
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree