Senior Director, Global Regulatory Operations
BeiGene
Full time
Business Management
United States
Hiring from: United States
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
Key Job Responsibilities:
Core Competencies, Knowledge, and Skill Requirements:
Communication & Interpersonal Skills:
Requirements:
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
Salary Range: $196,600.00 - $266,600.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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
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
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
- Fosters Teamwork
- 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
Salary Range: $196,600.00 - $266,600.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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