Regulatory Submissions Lead - FDA IND/NDA/BLA

BeOne Medicines; San Mateo (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BeOne Medicines is seeking a Senior Regulatory Affairs Associate to lead U.S. regulatory submissions, including INDs, NDAs, and BLAs.

You will coordinate cross-functionally with Regulatory Strategy, Publishing, and clinical teams to ensure timely, compliant submissions. The role requires hands-on IND preparation experience, strong communication, and meticulous attention to detail in a fast-paced environment.

Qualifications

• 2+ years of Regulatory Affairs experience including hands-on support of U.S. IND preparation
• Experience with CTD/eCTD and FDA regulations is desirable
• Not an entry-level position; requires regulatory submissions experience (IND/NDA/BLA)

Responsibilities

• Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements).
• Draft regulatory submission documents (e.g., IND components).
• Review regulatory documentation for accuracy, consistency, and completeness.
• Serve as primary execution lead and cross-functional coordinator for US submissions.
• Partner with Regulatory Strategists to translate plans into timelines and deliverables.
• Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing for submission readiness.
• Perform QC checks to ensure compliance with eCTD specs and FDA requirements.
• Liaise with Regulatory Publishing to support on-time, first-cycle quality submissions.
• Maintain IND, NDA, and BLA archives and document integrity.
• Monitor FDA guidance updates and drive continuous process improvements.

Skills

Regulatory submissions planning

Regulatory strategy collaboration

Strong written and verbal comms

Cross-functional teamwork

Attention to detail

Education

BA/BS in science or related field

2+ years in Regulatory Affairs OR 5+ years Regulatory Affairs

Tools

Veeva Vault BRIM

Microsoft Office

Adobe Acrobat Pro

Job description

BeOne Medicines is seeking a Senior Regulatory Affairs Associate to lead U.S. regulatory submissions, including INDs, NDAs, and BLAs.

You will coordinate cross-functionally with Regulatory Strategy, Publishing, and clinical teams to ensure timely, compliant submissions. The role requires hands-on IND preparation experience, strong communication, and meticulous attention to detail in a fast-paced environment.