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Senior Director, Global Regulatory Operations - Vernon, United States - BeiGene
Description
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.
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).
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.
Leads the development of departmental procedures and practices for GRO; Works cross-functionally to interpret and implement process efficiencies and priority.
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).
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.
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.
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.
BeiGene Global Competencies:
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
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