Associate Director - Regulatory Affairs

2 days ago

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Sumitomo Pharma America, Inc.

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1001 - 5000

Description

• The Associate Director is part of the Global Regulatory Affairs team • Ensure execution of regional regulatory strategy in line with global registration strategy • Provide regulatory support from proof of concept, development, registration, and post-approval • Responsible for providing internal expertise on FDA regulations governing promotion and advertising • Act as Regional Regulatory Leader and may also be assigned as Global Regulatory Leader

Requirements

• Doctorate preferred (Pharm.D., Ph.D., M.D., etc.) • Master’s degree required (preferably in a scientific discipline) • 6 – 8 years relevant experience in biotech or pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs

Benefits

• merit-based salary increases • short incentive plan participation • eligibility for our 401(k) plan • medical, dental, vision, life and disability insurances • unlimited paid time off • 11 paid holidays plus additional time off during the last week of December • 80 hours of paid sick time upon hire and each year thereafter