Senior Manager, Global Regulatory Device Labeling Strategy Lead
Remote
Overview:
Takeda’s Plasma-Derived Therapies (PDT) Business Unit is at the forefront of transforming patient care by developing plasma-derived therapies for rare and complex diseases. The Senior Manager, Global Regulatory Device Labeling Strategy Lead, will play a pivotal role in managing the regulatory device labeling strategies within this innovative unit.
Job Description:
About the Role:
As a key player in Takeda’s PDT R&D Organization, you will provide regulatory expertise and strategic guidance to various internal stakeholders, ensuring the development and maintenance of Instruction for Use (IFU) documents and device packaging labeling content. This role focuses on compliance with US and EU standards and guidelines while supporting new and revised prescribing information and packaging.
Key responsibilities include:
Leading cross-functional teams in the development and lifecycle management of labeling documents such as IFU, CCDS, USPI, and EU SmPC.
Developing and executing labeling strategies, including those for combination, Software as a Medical Device (SaMD), and standalone medical device products.
Providing strategic insight to ensure global regulatory requirements are met for assigned products, including advice on current labeling templates, tools, and Health Authority guidance.
Managing device labeling strategies for the PDT Business Unit and supporting regulatory teams with cross-functional collaboration.
Key Responsibilities:
Lead and manage global labeling teams to drive collaboration on labeling strategy and content.
Develop labeling strategies and content, ensuring compliance with internal and regulatory standards.
Author and revise key labeling documents, obtaining approval from relevant stakeholders.
Manage the preparation of labeling components and ensure timely communication with Health Authorities.
Oversee the tracking and QC of labeling documents in compliance with Takeda’s internal procedures.
Maintain up-to-date awareness of regulatory legislation and its impact on PDT products.
Minimum Requirements/Qualifications:
4-7 years of experience in the biopharmaceutical industry, with a preference for experience in plasma-derived therapies and biologics.
Bachelor's or Master's degree required; advanced scientific or health sciences degree preferred.
Knowledge of US and EU labeling requirements, including combination product labeling and SPL formats.
Proficiency in Electronic Document Management Systems and E2E Labeling Tracking Systems.
Success Profile:
Expertise in pharmaceutical drug and device development, with a focus on global labeling regulations.
Strong leadership skills with the ability to motivate and manage cross-functional teams.
Effective communicator with the ability to drive consensus across diverse stakeholders.
Innovative thinker who challenges the status quo and drives process improvements.
Benefits:
Competitive salary range: $137,000 - $215,270.
Access to comprehensive health benefits, including medical, dental, and vision insurance.
401(k) plan with company match, short-term and long-term disability coverage.
Paid time off, including sick time and vacation days.
Tuition reimbursement and company holidays.
Application Link:
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