The role involves planning, tracking, and executing U.S. regulatory submissions including INDs, NDAs, and BLAs for investigational and commercial products
Job Summary
The role involves planning, tracking, and executing U.S. regulatory submissions including INDs, NDAs, and BLAs for investigational and commercial products.
Candidates must possess prior Regulatory Affairs experience with hands-on support of U.S. IND preparation and a working knowledge of NDA submissions.
BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity ownership.
Matching Summary
The role involves planning, tracking, and executing U.S. regulatory submissions including INDs, NDAs, and BLAs for investigational and commercial products.
Salary
Base: $40.91 - $52.91 per hour; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO
Skills & Requirements
Must-have
Hands-on support of U.S. IND preparation
Working knowledge of NDA submissions
Experience with CTD/eCTD specifications
Proficiency in Veeva Vault RIM systems
FDA regulatory compliance execution
Nice-to-have
Entrepreneurial mindset in fast-paced environment
Strong cross-functional collaboration skills
Ability to adapt to changing FDA guidance
Proactive self-starter with organizational discipline
Key Requirements
BA/BS degree in scientific or health-related discipline
3+ years of Regulatory Affairs experience required
Prior hands-on support of U.S. IND preparation mandatory