Not specified (assumed to be hybrid or onsite based on industry norms).
Manage regulatory submissions
Plan regulatory activities
Provide regulatory guidance
BeOne is seeking a Manager of Regulatory Affairs with over five years of experience to oversee regulatory projects, manage submissions, and provide strategic guidance to cross-functional teams. The ideal candidate should have a strong background in IND submissions and a good understanding of FDA regulations, as well as excellent communication skills
Job Summary
BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals.
This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Matching Summary
Match Score: 85
BeOne is seeking a Manager of Regulatory Affairs with over five years of experience to oversee regulatory projects, manage submissions, and provide strategic guidance to cross-functional teams. The ideal candidate should have a strong background in IND submissions and a good understanding of FDA regulations, as well as excellent communication skills.
Salary
Base: $121,500.00 - $161,500.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Skills & Requirements
Must-have
Manage regulatory submissions
Plan regulatory activities
Provide regulatory guidance
Experience with INDs
Experience with CTD/eCTD
Knowledge of FDA and ICH regulations
Nice-to-have
Collaborative and motivated professionals
Passionate interest in fighting cancer
Entrepreneurial environment
Knowledge of other regions' requirements
Key Requirements
5+ years related experience
Bachelor's Degree
Experience with INDs
Experience with NDAs desirable
Experience with supportive amendments and supplements
Experience with publishing documents in Adobe Acrobat Professional
Working knowledge of GMP, GLP, and GCP regulations