Senior Director, Regulatory Affairs, CMC at BeOne Medicines

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. BeOne is seeking an accomplished and strategic Senior Director, Regulatory CMC to lead a group and oversee CMC regulatory strategy and execution for our Antibody-Drug Conjugate (ADC) portfolio cross development, registration, commercialization, and lifecycle management, with primary responsibility and accountability as a Global Regulatory Lead (RCL) for a late-stage ADC program advancing toward Biologics License Application (BLA) submission and Health Authority interactions. The successful candidate will bring a demonstrated track record of leading ADC program(s) from IND through BLA/MAA and Health Authority interactions, combined with strong people leadership and the ability to develop and lead a high-performing team, and work effectively in a global, culturally diverse, and matrixed project team. Essential Functions of the job: Lead and develop an U.S. based Regulatory CMC team overseeing CMC regulatory strategy and execution for the ADC portfolio across all phases of development and lifecycle management, including CMC dossier authoring, health authority interactions, and ensuring technical excellence and regulatory compliance. Global Regulatory Lead (RCL) leading regional members for a late-stage ADC program advancing toward BLA submission, responsible and accountable for the program’s global CMC regulatory strategy development, execution, Health Authority interactions, regulatory risk assessment and mitigation, CMC dossier preparation, finalization, and lifecycle management in accordance with applicable regulations and guidelines. Partner closely with global cross-functional stakeholders (e.g., CMC, Manufacturing, Quality, Supply Chain, Clinical, and GRA Teams) to ensure alignment on the overarching ADC CMC regulatory strategies, development plans, and execution. Lead and oversee regulatory CMC change-control impact assessments for ADC programs, ensuring appropriate regulatory strategies and filings are identified and executed in a timely and compliant manner. Lead and oversee regulatory risk management across the ADC portfolio, proactively identifying CMC related regulatory 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 ADC 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. Supervisory Responsibilities: The position manages a team of about 5 people based in US and manages a global project team in a matrix model. Education and Experience Required: BA/BS Degree in sceintific disciplines, MS/PhD preferred. 12+ years of relevant industry experience. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-