Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryThis position is responsible for collaborating within the Regulatory Affairs department and cross-functionally to ensure that roles and responsibilities, process steps and data within our processes are created, maintained, and aligned with health authority and business requirements. This role will partner and liaise globally to define, implement, and train the organization on global processes and align on developing the appropriate local processes to support health authority requirements. This position is responsible for identifying, defining, and implementing metrics to measure and monitor our processes to ensure they are compliant and operating within defined parameters. This position partners and liaises with the Quality Assurance function to ensure that regulatory processes adhere to global quality standards and practices. Additionally, this position partners with Quality Assurance to define and implement an inspection-readiness program to prepare and respond to health authority inspections. This role also partners with Quality Assurance to define and execute internal audits for Regulatory Affairs including the appropriate remediation within the department to address improvements. This position is responsible for defining and measuring the management of vendors that support regulatory activities within the department. The oversight of vendors is done in collaboration with the Quality Assurance and Sourcing functions to identify metrics and best practices to ensure our vendors deliver according to their contracts. This position is responsible for defining and implementing data governance practices within the implementation and maintenance of Regulatory Affairs processes and systems. This role partners with Regulatory Information Management, IT, and cross-functional subject-matter-experts to define data practices and curation across the organization.

Responsibilities

• Technology Data: Assesses the existing data and data requirements to support the creation and monitoring of metrics and Key Performance Indicators (KPIs) across the organization. Collaborates with Regulatory Information Management and IT to identify and implement the appropriate tools and systems to create reports, dashboards, and tools to monitor, trend and track metrics in the organization. Leads and contributes to the implementation of data governance, stewardship, and data curation activities in Regulatory Affairs.
• Strategy: Responsible for creating the strategy and setting initiatives to implement processes, continuous process improvement, and aligning Regulatory Affairs processes cross-functionally. Leads the development of metrics to measure Regulatory Affairs process performance and compliance. Provides thought leadership to improving and modernizing our processes, systems, and data practices to support a global organization.
• People: Collaborates and partners with others within Regulatory Affairs as well as cross-functionally. Provides leadership for process creation, maintenance and improvements globally and locally (as-needed) with the Regulatory Affairs department. Communicates effectively to global audiences on process, quality, and data initiatives in the organization.
• Creates Improves Processes: Leads the development, maintenance, and improvement of processes in the Regulatory Affairs department. Identifies and creates metrics and KPIs to measure process performance and compliance in the organization. Partners internally and cross-functionally to communicate and train the organization on new and updated processes in a compelling manner. Defines and measures processes and best practices to manage Regulatory Affairs vendors.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

• Bachelor's Degree in Life Sciences, Engineering or Sciences required Experience Qualifications

• 10 or More Years Experience in the pharmaceutical industry preferred
• 4 or More Years of direct regulatory affairs experience preferred

Physical RequirementsRemote with expectations to go into the office when required.% of TimeTravelAbility to travel up to 20% Travel to company headquarters and global affiliates as needed
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.