Director, Regulatory Affairs

November 28, 2024

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Sumitomo Pharma America, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Manage and develop talent; may train/mentor junior staff. • Manage regional regulatory activities as part of a Global Regulatory Team. • Leads regulatory activities for assigned project(s). • Plans, coordinates, authors, and prepares regulatory submissions. • Leads regional health authority meetings. • Ensure compliance with global regulatory requirements.

Requirements

• 8 – 12 years of relevant experience in biotech or pharmaceutical industry. • Minimum of 8 years focused in regulatory affairs. • Master’s degree required (preferably in a scientific discipline). • Experience contributing to electronic regulatory submissions. • Experience interacting with the FDA and ex-US Health Authorities. • Proven success/major involvement in NDA/MAA/CTD submissions and approval.

Benefits

• Merit-based salary increases. • Short incentive plan participation. • Eligibility for the 401(k) plan. • Medical, dental, vision, life, and disability insurances. • Unlimited paid time off. • 11 paid holidays. • 80 hours of paid sick time.