BeOne is seeking an accomplished and highly influential regulatory leader to head the U.S. Biologics Regulatory CMC organization. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle. The scope of responsibility includes, but is not limited to, monoclonal antibodies, antibody-drug conjugates (ADCs), cell therapies, and medical device-combination products. The role has accountability for CMC-related regulatory submissions and health authority interactions, ensuring high-quality, compliance, and timely filings that support clinical development, licensure, and post-approval lifecycle management. This leader will lead and continuously optimize biologics Regulatory CMC processes, ensuring alignment with evolving global regulatory expectations and BeOne's development and commercialization goals. The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC.
- Essential Functions of the job:
- + Lead, develop, and continuously strengthen the U.
S. Biologics Regulatory CMC team to ensure high performance, technical excellence, and regulatory compliance. + Provide strategic and operational leadership for the development and execution of global biologics Regulatory CMC strategies for the responsible regions, including oversight of authoring, review, and lifecycle management of CMC sections of CTDs (Modules 2 and 3) for INDs, BLAs, MAAs, and post approval submissions. + Lead and oversee biologics Regulatory CMC interactions with Health Authorities for the responsible regions, including preparation of CMC briefing packages, responses to agency questions, meeting support, and regulatory negotiations. + Partner closely with global cross-functional stakeholders (e.g., CMC, Manufacturing, Quality, Supply Chain, Clinical, and GRA Teams) to ensure alignment on overarching biologics CMC regulatory strategies, development plans, and execution for the responsible regions. + Lead and oversee regulatory CMC change-control impact assessments for biologics programs, ensuring appropriate regulatory strategies and filings are identified and executed in a timely and compliant manner for the responsible regions. + Lead and oversee regulatory risk management across the biologics portfolio, proactively identifying CMC risks, defining mitigation strategies, and escalating critical issues to senior management as appropriate. + Establish, maintain, and continuously improve Regulatory CMC standard operating procedures (SOPs), working instructions, and best practices to ensure consistency, compliance, and inspection readiness. + Ensure appropriate Regulatory CMC assessment, strategy, and execution in support of product quality issues, including recalls, deviations, and product complaints throughout the product lifecycle. + Review and approve Regulatory CMC documentation, including submissions, responses, and internal procedures, within the Regulatory Information Management (RIM) system. + Lead or oversee Regulatory CMC due-diligence activities for business development, licensing, and acquisition opportunities, including risk and gap assessments. + Represent the company and Regulatory CMC function in external forums, industry groups, and regulatory or scientific conferences as appropriate.
Computer Skills:
- + Microsoft 360
- Other Qualifications
- : + BA/BS Degree in scientific disciplines with 14+ years of relevant pharmaceutical experience, MS/PhD preferred and 10+/8+ years of relevant pharmaceutical or biopharmaceutical experience in innovative drug development, manufacturing, quality, or related CMC functions, including at least 8 years of direct Regulatory CMC experience.
+ Demonstrated track record of leading Health Authority interactions and supporting CTA/IND, BLA/MAA, and post-approval submissions, including management of agency questions and negotiations. + Proven experience leading and developing teams of 10+ or more professionals in a global, matrixed environment. + Advanced scientific training with hands-on expertise in at least one core pharmaceutical or biologics discipline (e.g., upstream or downstream processing, formulation, analytical development, manufacturing, QC, or QA). + Experience with gene therapy, cell therapy, and/or medical device-combination products is highly desirable. + In-depth knowledge of ICH guidelines and global Regulatory CMC requirements; familiarity with GMP and Quality Assurance regulations is a plus. + Extensive experience authoring, reviewing, and managing complex technical documentation, including CTD Modules 2 and 3 and their lifecycle management. + Excellent written and verbal communication skills, with the ability to clearly convey complex technical and regulatory concepts; multilingual capability is a plus. + Strong interpersonal and problem-solving skills, with the ability to influence, collaborate, and lead effectively in a fast-paced, global environment. + Experience using Regulatory Information Management systems such as Veeva Vault is a plus.
Supervisory Responsibilities:
- + Manage existing US based biologics regulatory CMC team of 10+ members.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
