Director, Global Regulatory Affairs & Clinical Safety (GRACS), Global Process Lead

Job Description

The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety global business processes. This includes defining and optimizing end-to-end processes and ensuring consistency and standardization across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and external functions such as our company's QA, GCD Standards, and Learning & Development. This collaboration is essential in developing and executing strategies that support the ongoing business needs of Global Regulatory Affairs and Clinical Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes.

Core Responsibilities may include and are not limited to:

• Establish and maintain an engaged SME network as well as collaborative, and innovative culture in Global Regulatory Affairs and Clinical Safety for business process management and continuous improvement. 

• Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design and performance of multiple global business processes ensuring alignment of global to local procedures.

• Collaborates with various SMEs, including leading cross-functional teams, to drive process improvements, streamline operations, and achieve business objectives on a global scale.

• Deep domain knowledge of the end-to-end process for their respective global business processes (e.g., enabling systems, upstream and downstream transfer of information and assets).

• Accountable for ensuring comprehensive and expert input into decisions/changes that affect business processes, roles and responsibilities, and role-based training associated with core business processes.

• Partner with Business System Owners on Alignment of Process & Technology.

• Develop &/or and manage process related artifacts (process maps, documentation, training content and role identification), ensuring alignment across impacted functional areas.

• Drive accountability for processes execution throughout Global Regulatory Affairs and Clinical Safety through change management. 

• Develop, implement and report process objectives and key performance indicators for assigned global process domains; Manage and report process performance against metric targets.

• Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.

• Lead large-scale change initiatives across Global Regulatory Affairs and Clinical Safety and engage across Global Regulatory Affairs and Clinical Safety leadership to identify Global Regulatory Affairs and Clinical Safety -level projects for continuous improvement of the organization, including managing the impact of final external regulatory policies that support work that is executed in Global Regulatory Affairs and Clinical Safety .

• Ensure organizational compliance with global regulations including integration of Final Policy requirements into core business processes and procedures. 

• Conduct process assessments, manage pre-requests, and participate in audits and inspections related to Global Regulatory Affairs and Clinical Safety processes.

• Develop and improve upon business process management organization capabilities (e.g., lean six sigma, change management, executive-level facilitation, project management, negotiations, etc.).

• Ensure alignment with cross-functionally outside of Global Regulatory Affairs and Clinical Safety and throughout the our company to develop and improve enterprise-wide process optimization.

• Represent our company, Global Regulatory Affairs and Clinical Safety , BCST, Process Management, Metrics and/or Knowledge Management profession in forums outside the department, including participation on M&A or Business Development Execution, as well as engagements outside the company

Education:

• Bachelor’s degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated environment.

• Master’s Degree and a minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with technical systems in a regulated en