Senior Associate, Regulatory Affairs (US)

About the role

The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross-functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements.

Responsibilities

• Coverage of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements)
• Draft regulatory submission documents (e.g., IND components) as required
• Review regulatory documentation to ensure accuracy, consistency, and completeness
• Support the effective execution of regulatory submissions to health authorities
• Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies
• Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and other cross-functional teams to collect and organize FDA submission-ready documents
• Perform Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements
• Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions
• Utilize regulatory tracking tools (e.g., Veeva Vault RIM, submission trackers) to monitor milestones, deliverables, and risks
• Maintain IND, NDA, and BLA submission archives ensuring version control, document integrity, and inspection readiness
• Request FDA application numbers via the CDER NextGen Portal and support FDA correspondence tracking
• Monitor FDA guidance updates and contribute to continuous improvement of US submission processes

Requirements

• Prior Regulatory Affairs experience, including hands-on support of U.S. IND preparation
• Experience with CTD/eCTD
• Experience with publishing documents in Adobe Acrobat Professional
• Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations

Qualifications

• Bachelor's degree, preferably in a scientific or health-related discipline
• 2+ years OR 5+ years of Regulatory Affairs experience, including hands-on support of U.S. IND preparation

Skills

• Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Ability to manage submission timelines, trackers, and Master Document Lists

Benefits

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.

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.

The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.