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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.

As a key leader within Global Labeling Operations, the Director, Labeling Council and Regional Labeling, will provide direction and leadership for activities related to regional labeling and Global Labeling Council. Responsible for establishing a new capability to support Local Operating Company Regulatory Affairs professionals (LOCs) with management of on-time submissions, including acting as point of contact for questions related to dependencies, lead/dependent markets, hybrid labels, labeling processes, tools, and systems. Responsible for oversight and adjustment to expectations for the team and stakeholders. Leads the Global Labeling Council.

How you will contribute:

• Partner with the Head of GRA Labeling Operations to facilitate Labeling Council.

• Lead Labeling Council Meetings: Facilitate discussions, document key decisions, and ensure active participation from stakeholders to align on labeling initiatives, strategies and regulatory requirements.

• Track and Follow Up on Action Items of Labeling Council Meetings: Monitor progress of assigned tasks, provide updates, and address challenges to maintain accountability and ensure timely execution of decisions.

• Drive activities to support Local Operations Company (LOC) Regulatory Leads towards achievement of seamless execution of labeling processes and continuous process improvement. As primary point of contact for LOC questions related to labeling process changes, conduct awareness sessions with LOCs to ensure LOC understands how any process change impacts their ways of working.

• Partner with key stakeholders, including Global Labeling, EUCAN Regulatory Liaison and GEM Area Heads to enable excellent in the execution of the labeling processes globally.

• Reports on regional labeling activities to stakeholders and leadership.

• Supports standardization of implementation of Global Labeling processes and the use of the RIM system and labeling tracking system at the LOC level.

• Build and nurture awareness of the role of regional labeling to act as the conduit between Global Labeling Leads (strategy) and LOCs.

• Establish an environment that supports LOCs in labeling activities, leading forums and workshops as necessary.

• Provides strong SME knowledge of labeling processes and regulations as they relate to creation of local labeling, including content exceptions and submission timeline extensions.

• Partners with Labeling Conformance to proactively support on-time submissions of local labels related to global changes, including the necessary activities in labeling tracking systems.

• Develop and monitor metrics for regional labeling to identify insights and propose and execute on strategic actions for continuous improvement and compliance.

• Demonstrates Takeda leadership behaviors.

Minimum Requirements/Qualifications:

• Bachelors degree (or equivalent) required, masters preferred.

• 7+ years experience in pharmaceutical industry, with 4 years in Regulatory Affairs, labeling or quality assurance/compliance.

• Labeling SME – Extensive labeling process SME knowledge, both global and local, and the ability to train/support LOCs and the regional labeling team in their understanding of the processes.

• Industry Knowledge – Understands the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes. Awareness of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.

• Project management and Six Sigma experience preferred.

• Leadership – Comfortable working across functions, regions and cultures. Proven skill as an effective team leader preferred, demonstrated ability to engender credibility and confidence within and outside the company.

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.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

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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:

$174,500.00 - $274,230.00

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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