Sumitomo Pharma America, Inc.

Compensation

Full Description

Job Description: • Manage and train/mentor junior staff • Lead the development and implementation of regulatory strategy • Manage regional regulatory activities as part of a Global Regulatory Team • Plan, coordinate, author, and prepare regulatory submissions • Ensure compliance with global regulatory requirements Requirements: • Bachelor’s degree in a related field required • 10+ years of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs • Master’s degree preferred (preferably in a scientific discipline) • Strong verbal and written communication skills • Advanced understanding of medical terminology, and FDA and ICH regulations/guidance documents Benefits: • merit-based salary increases • short incentive plan participation • eligibility for 401(k) plan • medical, dental, and vision insurances • life and disability insurances • leaves provided in line with work state • flexible paid time off • 11 paid holidays • additional time off for shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter