- Remote, United States
- Remote
- Full-time
- $94K–$124K per year
- 3+ years
The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products, serving as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders.
Compensation
Salary Range: $93,600.00 - $123,600.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
Responsibilities
- Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance.
- Draft regulatory submission documents (e.g., IND components) as required.
- Review regulatory documentation to ensure accuracy, consistency, and completeness, and support the effective execution of regulatory submissions to health authorities.
- Serve as the primary execution lead and cross‑functional coordinator for assigned U.S. regulatory submissions, ensuring clarity of roles, timelines, and deliverables.
- Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies.