Director, Veeva RIM Business System Owner
Takeda
Summary
The Director, Business System Owner – Veeva RIM is accountable for defining and delivering the business technology strategy, roadmap, and operational excellence for Takeda’s Veeva Regulatory Information Management platform. As the accountable Business System Owner, this role ensures alignment of the platform with regulatory priorities, enterprise data strategy, and evolving compliance requirements. The role drives cross-functional collaboration to continuously enhance system capabilities, regulatory processes, and data integrity, enabling efficient and scalable regulatory operations globally.
Job description
Accountabilities
- Serve as accountable Business System Owner for Veeva RIM, ensuring the platform remains compliant, scalable, and aligned to business needs
- Define and execute the multi-year system strategy and roadmap aligned to GRIDS and GRA priorities
- Lead prioritization of system enhancements based on business value, regulatory risk, and operational impact
- Establish and track KPIs to measure value realization, efficiency gains, and data quality improvements
- Own system lifecycle governance, including roadmap planning, release management, and enhancement delivery
- Partner with Digital & Technology and vendors to ensure system stability, performance, and scalability
- Establish governance forums to drive stakeholder alignment and decision-making
- Serve as the primary interface across GRIDS, regulatory functions, and Digital for system-related decisions
- Drive change management, communication, and adoption strategies
- Ensure alignment with regulatory processes, data governance standards, and inspection readiness expectations
- Enable robust regulatory data governance, data quality, and analytics capabilities
- Lead and influence across a global matrix organization, fostering collaboration and continuous improvement
Education & Experience
- Bachelor’s degree required; advanced degree preferred
- 12+ years of experience in Regulatory Affairs across global functions
- Proven experience as a Business System Owner or equivalent leadership role
- Experience with Veeva RIM or comparable regulatory systems
Technical Competencies
- Deep expertise in regulatory processes and lifecycle management
- Strong capability in translating business needs into system capabilities and features
- Advanced knowledge of regulatory data, governance, and compliance requirements (e.g., IDMP)
- Experience defining and measuring KPIs for system value realization
Behavioral & Leadership Competencies
- Strong executive presence and stakeholder influence
- Ability to operate effectively in a global, matrixed environment
- Strategic thinking with strong execution and outcome orientation
- Excellent decision-making and prioritization capabilities
- Strong communication and change leadership skills
- Commitment to fostering innovation, accountability, and continuous improvement
Requirements
- Bachelor’s degree required; advanced degree preferred
- 12+ years of experience in Regulatory Affairs across global functions
- Proven experience as a Business System Owner or equivalent leadership role
- Experience with Veeva RIM or comparable regulatory systems
- Deep expertise in regulatory processes and lifecycle management
- Strong capability in translating business needs into system capabilities and features
- Advanced knowledge of regulatory data, governance, and compliance requirements (e.g., IDMP)
- Experience defining and measuring KPIs for system value realization
- Strong executive presence and stakeholder influence
- Ability to operate effectively in a global, matrixed environment
- Strategic thinking with strong execution and outcome orientation
- Excellent decision-making and prioritization capabilities
- Strong communication and change leadership skills
- Commitment to fostering innovation, accountability, and continuous improvement
Benefits
- Hybrid work policy
- Competitive base salary
- Comprehensive benefits package
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.