Director of Regulatory Affairs, Global Labeling

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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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include products of medium complexity and updates to TLP, CCDS, USPI and EU SmPC. You will also be responsible for providing support to the development and implementation of labeling content and strategy of high complexity product(s).

How you will contribute :

With appropriate supervision and guidance :

Management of Labeling Cross-Functional Teams

Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervision and guidance.

Assists in the development of labeling strategies and content and to ensuring cross-functional alignment for other medium and / or high complexity products.

Interface with Senior Management Cross-Functional Team (GLOC)

Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels, with appropriate supervision, guidance and alignment with TAU / MPD Labeling Lead.

Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.

Labeling Documents Authoring, Submission, and Labeling Negotiations

Authors revised TLP, CCDS, USPI and / or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation, with appropriate supervision and guidance.

With appropriate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs.

Authors / manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance.

Employs project management skills to interface with global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and participates in label negotiations with Health Authorities.

Ensures labeling content conform to regulatory requirements.

Management of Local Exceptions and LOC Interactions

Manages the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance.

Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.

Escalation Process and Stakeholder Management

Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.

Proactively strengthen and foster robust relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure highly effective communication of labeling strategy and content.

Precedent Search and Labeling Trends

Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.

Working within Labeling Team and GRA

Represents Global Labeling at Global Regulatory Team (GRT)

Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.

Participates in departmental and cross-functional task-forces and initiatives.

Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products.

Support in Managing Labeling Deliverables for Medium and / or High Complexity Products

Assist in managing high complexity products by working with GLLs and labeling management on assigned labeling tasks such as review and edit labeling documents, assist in leading LWG meetings, coordinate labeling local update / exception process etc.

Vendor Management

Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.

Minimum Requirements / Qualifications :

BSc degree, preferred; BA accepted.

Advanced scientific degree (MSc, PhD, or PharmD) preferred.

6+ years of pharmaceutical industry experience. This is inclusive of 4 years of labeling experience or combination of 4+ years regulatory and / or related experience.

Knowledge of US and EU product labeling regulatory requirements and guidelines.

Familiarity with US and / or EU regulatory requirements and guidelines.

Familiarity with other relevant regional regulatory nuances and requirements.

Basic knowledge of scientific principles and regulatory / quality systems relevant to drug development.

Ability to co-author, revise and / or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions with appropriate supervision and guidance.

Ability to identify factors and requirements necessary for regulatory recommendations.

Ability to develop regulatory strategies based on regulatory requirements and competitive landscape.

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.

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 :

$137,000.00 - $215,270.00

The estimated sa