Associate Director, Regulatory Business Systems & Capability Strategy
Takeda
Summary
The Associate Director, Regulatory Business Systems & Capability Strategy supports the definition and execution of regulatory capability strategy within GRIDS. This role partners with Business System Owners and Business Process Owners to translate regulatory needs into scalable system capabilities, ensuring alignment across business, process, and technology. Operating as a key contributor within capability initiatives, the role enables structured requirements definition, cross-functional alignment, and consistent delivery of regulatory system enhancements that improve efficiency, compliance, and data quality.
Job description
Objective / Purpose
The Associate Director, Regulatory Business Systems & Capability Strategy supports the definition and execution of regulatory capability strategy within GRIDS. This role partners with Business System Owners and Business Process Owners to translate regulatory needs into scalable system capabilities, ensuring alignment across business, process, and technology. Operating as a key contributor within capability initiatives, the role enables structured requirements definition, cross-functional alignment, and consistent delivery of regulatory system enhancements that improve efficiency, compliance, and data quality.
Accountabilities
- Support development and refinement of regulatory capability roadmaps aligned to GRA priorities
- Partner with Business System Owners to structure and prioritize demand, backlog, and enhancements
- Elicit, document, and refine business requirements, ensuring clarity, completeness, and alignment to regulatory needs
- Facilitate cross-functional workshops with SMEs and Process Owners to define use cases and business scenarios
- Translate business needs into structured requirements, supporting downstream design and delivery activities
- Ensure consistency and reuse of requirements, capabilities, and design patterns across initiatives
- Coordinate with Digital & Technology teams to support delivery and implementation of solutions
- Identify opportunities for process optimization, standardization, and system improvements
- Support adoption of best practices in capability modeling, requirements management, and delivery execution
Education & Experience
- Bachelor's degree required; advanced degree preferred
- 8–12+ years of experience in Regulatory Affairs or related domain
- Experience working with regulatory systems (RIM preferred)
- Experience supporting cross-functional initiatives and requirements-driven delivery
Technical Competencies
- Strong understanding of regulatory processes and lifecycle activities
- Requirements elicitation, analysis, and documentation expertise
- Understanding of system capabilities, data structures, and process integration
- Ability to translate business needs into structured and actionable requirements
Behavioral & Leadership Competencies
- Strong collaboration and stakeholder engagement across business and technology teams
- Execution-oriented with focus on quality and delivery outcomes
- Analytical thinking and structured problem-solving
- Clear communication and facilitation skills
- Continuous improvement mindset with learning agility
- Ability to operate effectively within a global, matrixed environment
Requirements
- Bachelor's degree required
- 8–12+ years of experience in Regulatory Affairs or related domain
- Experience working with regulatory systems (RIM preferred)
- Experience supporting cross-functional initiatives and requirements-driven delivery
- Strong understanding of regulatory processes and lifecycle activities
- Requirements elicitation, analysis, and documentation expertise
- Understanding of system capabilities, data structures, and process integration
- Ability to translate business needs into structured and actionable requirements
- Strong collaboration and stakeholder engagement across business and technology teams
- Execution-oriented with focus on quality and delivery outcomes
- Analytical thinking and structured problem-solving
- Clear communication and facilitation skills
- Continuous improvement mindset with learning agility
- Ability to operate effectively within a global, matrixed environment
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.