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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

How you will contribute:

• Provides operational oversight to the activities related to regulatory information management data and system maintenance, guiding the team through challenges and aligning with the overall business strategy.

• Contributes to the development, implementation, and governance of RIM system enhancements, identifying innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap.

• Promotes regulatory information quality, reporting, and development and monitoring of KPIs to ensure quality.

• Develops, in coordination with Head of RIM, continuous improvement of existing RIM processes and KPIs.

• Supports effective migration of Regulatory Information resulting from M&A and Integration activities.

• Works closely with cross-functional stakeholders to manage and support complex RIM and migration scenarios.

• Responsible for compliance with data standards and reporting requirements as well as necessary Health Authority interaction (e.g., XEVMPD, IDMP), while working proactively to identify and mitigate any risks or gaps in data and regulatory strategy.

• Responsible for supporting Regulatory components of PSMF reporting, adapting strategies based on evolving global regulatory landscape.

• Acts as a primary source for business RIM system and process support, fostering transparency and collaboration across teams.

• In coordination with Head of RIM, provides leadership and direction to external partners and vendors on regulatory specifications for information management, aligning with Takeda’s and Health Authority expectations, ensuring flawless execution.

• Manages and drives Regulatory information management projects across the business

• In coordination with Head of RIM, Manages and drives Regulatory information management projects across the business, seeking input from diverse stakeholders to drive innovative solutions and ensure timely execution.

• Stays up to date on agency-related expectations for information management projects (e.g., IDMP, xEVMPD), identifying potential risks and providing creative mitigation steps.

• Manages and oversees vendor(s) in relation to RIM supported activities and information management projects, ensuring compliance with regulatory standards while fostering strong partnerships.

• Supports the development of procedure documents and best practices for RIM, ensuring these are aligned with industry standards and Takeda’s internal guidelines.

• Provides independent leadership and direction on regulatory specifications for RIM systems, working closely with cross-functional teams to achieve shared goals.

• Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively addressing challenges that arise during development and commercialization.

• Involves team members and stakeholders in the decision-making process, clearly communicates objectives, engages in brainstorming with team members and stakeholders to identify ways to move project/task forward.

• Demonstrates Takeda Leadership behaviors by building framework of trust through communication, transparency and mutual accountability.

Minimum Requirements/Qualifications:

• Bachelor’s degree or equivalent experience is required. A degree in a scientific or closely related field is preferred.

• 8+ years of experience in the pharmaceutical industry, with 6+ years in Regulatory Affairs, quality assurance/compliance, or research and development.

• Extensive experience in global drug development regulations, regulatory submissions, lifecycle management, and information management processes.

• Knowledge and experience with industry standards (e.g., IDMP, xEVMPD) and demonstrated ability to implement solutions in undefined regulatory frameworks.

• Experience managing vendors and contracts, including overseeing project deliverables and ensuring compliance.

• Proven ability to provide regulatory advice and make reasoned decisions on complex issues.

• Ability to work effectively in a matrix structure and complex environments, demonstrating leadership, problem-solving, and flexibility.

• Excellent written and verbal communication skills required.

• Expertise in Veeva Vault RIM; demonstrates a thorough understanding of the platform's features and functionalities, including document management, submissions and registrations modules, and reporting capabilities.

• Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, drug distribution process) and extensive expertise in global regulatory information management (e.g., xEVMPD, IDMP).

• Ability to apply a broad functional knowledge of Regulatory Affairs (RA) and Chemistry, Manufacturing, and Controls (CMC) domains to influence global strategies and deliver results.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$149,100.00 - $234,300.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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