Senior Director, Regulatory Affairs, CMC

BeiGene

11d • $204,500 - $274,500

About The Position

BeOne is seeking an accomplished, strategic Senior Director to lead a U.S.-based Regulatory CMC team and oversee CMC regulatory strategy and execution for its Antibody-Drug Conjugate (ADC) portfolio across development, registration, commercialization, and lifecycle management. The role has primary responsibility and accountability as Global Regulatory Lead for a late-stage ADC program advancing toward a Biologics License Application (BLA) submission and Health Authority interactions. The successful candidate will have a demonstrated record leading ADC programs from IND through BLA/MAA and Health Authority interactions, strong people leadership, and the ability to build a high-performing team and work effectively in global, culturally diverse, matrixed teams.

The position manages a team of about five people based in the U.S. and manages a global project team in a matrix model. BeOne seeks professionals who are highly motivated and collaborative and share its interest in fighting cancer.

Requirements

• BA/BS degree in a scientific discipline.
• 12+ years of relevant industry experience.
• Demonstrated track record leading ADC program(s) from IND through BLA/MAA and Health Authority interactions.
• Strong people leadership and ability to develop and lead a high-performing team.
• Ability to work effectively in a global, culturally diverse, matrixed project team.

Nice To Haves

• MS or PhD degree.

Responsibilities

• Lead and develop a U.S.-based Regulatory CMC team overseeing CMC regulatory strategy and execution for the ADC portfolio across development and lifecycle management, including dossier authoring, Health Authority interactions, technical excellence, and regulatory compliance.
• Serve as Global Regulatory Lead for a late-stage ADC program, leading regional members and taking accountability for global CMC regulatory strategy, execution, Health Authority interactions, risk assessment and mitigation, dossier preparation and finalization, and lifecycle management.
• Partner with global cross-functional stakeholders, including CMC, Manufacturing, Quality, Supply Chain, Clinical, and GRA teams, to align ADC CMC regulatory strategies, development plans, and execution.
• Lead and oversee regulatory CMC change-control impact assessments and ensure appropriate regulatory strategies and filings are identified and completed in a timely, compliant manner.
• Lead and oversee regulatory risk management across the ADC portfolio, proactively identifying CMC-related risks, defining mitigation strategies, and escalating critical issues to senior management as appropriate.
• Establish, maintain, and continuously improve Regulatory CMC standard operating procedures, working instructions, and best practices to support 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 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.

Benefits

• Medical, dental, and vision coverage.
• 401(k).
• FSA/HSA.
• Life insurance.
• Paid time off.
• Wellness benefits.
• Eligibility for discretionary equity awards.
• Voluntary participation in the Employee Stock Purchase Plan.
• Non-Commercial roles are eligible to participate in the annual bonus plan; Commercial roles are eligible for an incentive compensation plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior