Senior Director, Global Regulatory Operations

Emeryville, CA, United States

**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 of RIM projects based on current and future business needs (requirements)

+ Provide oversight for the implementation of systems, tools, and processes to ensure timely support and prioritization.

+ Leads the design, development, and implementation strategies for global/regional dossier management and planning.

+ Leads budgeting and forecasting activities for the Global Regulatory Operations function including managing vendors) and external consultant budgets.

**Core Competencies, Knowledge, and Skill Requirements:**

+ Interact with and influence global, regional, and local colleagues and must have experience in managing projects with international scope and team.

+ Proven internal and external leadership and ability to work cross-functionally and globally and possess strong communication and interpersonal skills.

+ Extensive knowledge of global submissions and regulatory operations processes.

+ Extensive knowledge in the implementation of GxP Systems [e.g. Document Management Systems (e.g. Veeva), formatting (e.g. authoring templates) and publishing software systems (e.g. IP, Lorenz)]

+ Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of diplomacy and pragmatism.

+ Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio).

+ Clear understanding of the role that Regulatory Systems and user adoption plays in creating Regulatory efficiencies.

**Communication & Interpersonal Skills:**

+ Excellent interpersonal, communication, analytical and organizational skills.

+ Ability to translate evolving industry standards and requirements into company's best practices.

+ Demonstrate leadership capacity in a highly matrix working environment by interacting effectively with internal and external departments and external organizations.

+ Be comfortable with making high level and strategic decision but also capable of driving results through hands-on leadership.

+ Proven project management and time management skills.

**Requirements:**

+ Education: Bachelor's degree required; Master's degree preferred.

+ Required Experience: Minimum of 12 years Regulatory Affairs and/or Regulatory Operations experience in the pharmaceutical/biotechnology industry or Government Health Agency.

+ Preferred Experience: Minimum 10 years' experience in a Regulatory Operations leadership role.

+ Business travel up to 20% or as required.

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.