Senior Director, Global Regulatory Operations

BeiGene 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.

Position Summary:

The Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. The head of GRO and GRA Excellence will represent the department across the organization on various impactful programs and projects that support BeiGene's corporate vision, mission, and values.

As the Head of Global Regulatory Operations, the SD will lead key functions (Submission Operations Management (SOM), Process and Standards, and Regulatory Information Management & Technology (RIMT) to enable implementation and support of key programs and industry best practice submission processes.

The SD will successfully lead the Global Regulatory Affairs organization in identifying and guiding process optimization and streamlining departmental culture efforts within the GRA department. The SD will facilitate departmental (process, people) solutions from concept through implementation. The solutions defined will be translated to business process and departmental updates as appropriate.
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Key Job Responsibilities:

• Manage KPI review with global and regional leadership. Identify challenges, opportunities, risks, and drive solutions accordingly.

• Oversee design and implementation of GRA re-engineered business processes to maximize efficiency and incorporate compliance driven industry standards (includes engaging consultants and vendors to support activities)

• Coordinate and oversee cross-functional projects for achieving operational goals.

• Assess impact on effective processes &develop mutually agreed optimized processes and drive key cross functional initiatives and business improvements.

• Partner with and/or lead a team of key GRA stakeholders (i.e., Business Transformation,) to integrate R&D, BeiGene and GRA initiatives and goals.

• Support department personnel development initiatives including talent planning and performance management in partnership with R&D &Regulatory key stakeholders (Chief of Staffs), Business Operations and HR function to ensure global and consistent approach.

• Lead all operational aspects of global regulatory submission dossier compilation ensuring submission timelines and quality standards are met.

• Leads the development of departmental procedures and practices for GRO; Works cross-functionally to interpret and implement process efficiencies and priority.

• Interacts and consults with Health Authorities/Regulatory Agencies (e.g. FDA, EMA, CFDA) ot ensure BeiGene practices (e.g. quality control checks) are aligned with HA regulation and industry best practices

• Provide cross-functional leadership for complex global filings, including leading collaboration with external partners.

• Provide Regulatory Information Management (RIM) program leadership by overseeing the development …