Biologics Regulatory CMC Leader - U.S.

Regulatory Jobs; United States; Remote; USD 275,000 - 355,000; Full time

Benefits offered by this job

Medical benefits

Equity opportunities

Bonus program

401(k)

Job summary

BeOne Medicines Ltd. seeks an accomplished regulatory leader to head the U.S. Biologics Regulatory CMC organization, delivering strategic direction and operational excellence for regulatory submissions and health authority interactions across monoclonal antibodies, ADCs, and cell therapies.

The role oversees a U.S.-based team (~15) and collaborates with global partners to align regulatory strategies with development plans, ensuring timely, compliant filings throughout lifecycle management.

Qualifications

• 14+ years in pharmaceutical or biopharmaceutical sectors with extensive Regulatory CMC experience.
• Track record leading Health Authority interactions and CTD Modules 2 and 3 submissions.
• Experience building and leading global, matrixed teams in a fast-paced environment.

Responsibilities

• Lead and develop the U.S. Biologics Regulatory CMC team for high performance and compliance.
• Develop and execute global CMC regulatory strategies across INDs, BLAs, MAAs, and post‑approval filings.
• Manage regulatory agency interactions, briefing packages, and negotiation responses.

Skills

CMC Leadership

Regulatory Strategy

Health Authority Interactions

Global Collaboration

Team Development

Regulatory Submissions

Veeva Vault

Education

BA/BS in life sciences

MS/PhD preferred

Tools

Veeva Vault

Job description

BeOne Medicines Ltd. seeks an accomplished regulatory leader to head the U.S. Biologics Regulatory CMC organization, delivering strategic direction and operational excellence for regulatory submissions and health authority interactions across monoclonal antibodies, ADCs, and cell therapies.

The role oversees a U.S.-based team (~15) and collaborates with global partners to align regulatory strategies with development plans, ensuring timely, compliant filings throughout lifecycle management.