Associate Director, Regulatory Affairs – Oncology

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October 11

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Sumitomo Pharma America, Inc.

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT) • leads regulatory activities for assigned project(s) in line with the global registration strategy of the product • develops regulatory strategy and provides regulatory input as appropriate • ensures compliance with global regulatory requirements and coordination of regulatory compliance activities at a global level • provides updates to the Global Regulatory Team, project teams, and governance boards as needed • maintains professional working relationships with colleagues, fostering collaboration, and idea sharing • reviews nonclinical, clinical and CMC documentation and contributes to content as needed

🎯 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

🏖️ Benefits

• merit-based salary increases • short incentive plan participation • eligibility for our 401(k) plan • medical, dental, vision, life and disability insurances • flexible paid time off • 11 paid holidays • 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