Senior Manager, Global Regulatory Device Labeling Strategy Lead

BioSpace; Boston (MA); Hybrid; USD 133,000 - 209,000; Full time

Job summary

A leading company in plasma-derived therapies is seeking a Senior Manager for Global Regulatory Device Labeling Strategy. This role involves developing labeling strategies, ensuring compliance with regulations, and leading cross-functional teams. The position offers a hybrid work model in Boston, MA, and a competitive salary.

Benefits

Comprehensive benefits package

Commitment to diversity

Focus on innovation and growth

Qualifications

• 4-7 years of experience in the biopharmaceutical industry.
• Up to 3 years in a global, US, or EU labeling role.

Responsibilities

• Lead cross-functional teams for labeling strategies.
• Manage labeling development and compliance for products.
• Innovate labeling strategies for product commercialization.

Skills

Regulatory Expertise

Labeling Strategy

Stakeholder Engagement

Education

Bachelor’s or Master’s degree

Tools

Electronic Labeling Systems

Document Management

Job description

Senior Manager, Global Regulatory Device Labeling Strategy Lead

Join to apply for the Senior Manager, Global Regulatory Device Labeling Strategy Lead role at BioSpace.

This position is based in Boston, MA, and offers a hybrid work model.

Job Description

About the role: The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to developing new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases.

Role: The Global Regulatory Device Labeling Strategy Lead (Senior Manager) in the PDT Business Unit (PDT BU) plays a key role in Global Labeling, reporting to the Head of Global Labeling. Responsibilities include providing regulatory expertise, developing labeling strategies, and ensuring compliance with US and EU standards for device labeling and instructions for use (IFU).

Key Responsibilities:

• Lead cross-functional teams to develop and align labeling strategies for IFU and global labeling documents.
• Develop regulatory labeling strategies for new and revised prescribing information and packaging.
• Provide guidance on current labeling requirements, templates, and health authority guidance.
• Serve as the device labeling expert on global Regulatory Affairs teams.
• Manage labeling development, lifecycle, and compliance for assigned products.
• Author and review labeling content, ensuring regulatory and internal approval.
• Innovate labeling strategies to support product commercialization and global expansion.
• Engage stakeholders, resolve conflicts, and ensure timely updates to labeling documentation.

Minimum Requirements:

• 4-7 years of experience in the biopharmaceutical industry, with up to 3 years in a global, US, or EU labeling role.
• Bachelor’s or Master’s degree; advanced degrees preferred.
• Deep understanding of pharmaceutical and device development, with expertise in US and EU labeling regulations.
• Experience with electronic labeling systems and document management.

Additional Information:

Takeda offers a comprehensive benefits package, a commitment to diversity, and a focus on innovation and growth. The salary range for this role is $133,000 - $209,000, dependent on experience and qualifications.