Global Regulatory Strategy & Submissions Lead

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

Job summary

BeOne Medicines Ltd. seeks an experienced Regulatory Affairs Manager to plan, coordinate, and complete submissions aligned with company goals.

You will represent Regulatory Affairs on cross‑functional teams and guide strategy and tactics for US and international submissions. The role requires leading IND/ NDA filings, CTD/eCTD publishing, and timely preparation of annual reports, safety updates, and amendments.

Qualifications

• 7+ years regulatory experience with a BA/BS
• Experience preparing INDs and NDAs and related amendments
• Familiarity with CTD/eCTD structure and publishing
• Working knowledge of FDA/ICH guidance and regulations
• Understanding FDA organization and global regulatory requirements
• Experience with GMP/GLP/GCP principles in pharma
• Strong written and oral communication; detail‑driven and proactive

Responsibilities

• Plan and manage regulatory activities across clinical, non-clinical, and CMC areas
• Develop strategies for earliest approvals/clearances for submissions
• Lead preparation, review, and submission of regulatory dossiers (INDs, NDAs, amendments)
• Maintain submissions in compliance; prepare meeting requests and briefing documents
• Contribute regulatory expertise to project teams and author annual reports
• Keep current with regulatory developments and coordinate with CROs/consultants

Skills

Regulatory submissions

IND/NDA experience

CTD/eCTD

FDA regulations

Cross-functional leadership

Regulatory strategy

Adobe Acrobat Pro

Project management

GMP/GLP/GCP knowledge

Communication skills

Education

BA/BS degree

Tools

Adobe Acrobat Pro

Job description

BeOne Medicines Ltd. seeks an experienced Regulatory Affairs Manager to plan, coordinate, and complete submissions aligned with company goals.

You will represent Regulatory Affairs on cross‑functional teams and guide strategy and tactics for US and international submissions. The role requires leading IND/ NDA filings, CTD/eCTD publishing, and timely preparation of annual reports, safety updates, and amendments.