RA Manager
$114,100–$211,900 year
Hybrid · Princeton, New Jersey, United States
Job Summary
RA Manager to support the US Biosimilar Regulatory Affairs team, responsible for operational execution of regulatory deliverables including US eCTD documents, timely submissions and approvals, and lifecycle management for biosimilar products. Responsibilities include coordinating regulatory information across departments, preparing regulatory documentation, HA interactions planning, and contributing to launch activities; requires deep regulatory knowledge of FDA, EMA, MHRA regulations, strong project-management, writing and documentation skills, and ability to work in a hybrid environment. Studio/hybrid policy allows up to 50% remote time; located at Princeton, NJ.
Required Qualifications
- Bachelor in science required
- 3-5 years experience in regulatory affairs, preferably in biosimilars
- Fluent English required (oral and written)
Additional Requirements
- U.S. work authorization required; U.S. work visa sponsorship is not available for this role now or in the future
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