The role involves managing regulatory aspects of compounds through all phases of development, post-approval, and life-cycle commitments
Job Summary
The role involves managing regulatory aspects of compounds through all phases of development, post-approval, and life-cycle commitments.
Candidates must provide strategic regulatory guidance to teams ensuring the latest industry requirements and standards are met.
BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity ownership.
Matching Summary
The role involves managing regulatory aspects of compounds through all phases of development, post-approval, and life-cycle commitments.
Salary
Base: $146,700.00 - $196,700.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off
Skills & Requirements
Must-have
8+ years regulatory experience
IND/CTA NDA/BLA/MAA submissions
FDA ICH regulatory requirements knowledge
Health authority interaction management
Regulatory team leadership and mentorship
Nice-to-have
Advanced degree preferred
Project lead experience with FDA interactions
Strong conflict resolution and negotiation skills
Entrepreneurial mindset and bold ingenuity
Ability to drive innovative regulatory strategies
Key Requirements
Bachelor's degree with 8+ years related regulatory experience
Proven track record in INDs NDAs BLAs MAA lifecycle management
Demonstrated managerial and collaboration ability across functional areas