Senior Manager, Global Regulatory Device Labeling Strategy Lead
Location: Boston, Massachusetts
Job Description
As a trusted global leader, Takeda's Plasma-Derived Therapies (PDT) Business Unit is committed to transforming the lives of patients worldwide through innovative plasma-derived therapies. We are looking for a Senior Manager, Global Regulatory Device Labeling Strategy Lead to provide regulatory expertise and strategic guidance for the development and maintenance of device labeling documents in line with US and EU standards. This role plays a key part in ensuring successful product development while maintaining compliance with Health Authority guidelines.
Responsibilities:
Strategic Labeling Leadership: Develop regulatory strategies for the IFU, CCDS, USPI, and EU SmPC for assigned products. Lead cross-functional teams to ensure alignment and collaboration in developing labeling strategies and content.
Regulatory Compliance: Ensure adherence to US and EU regulations and guidelines for pharmaceutical drug and device labeling. Provide strategic insight on the development of new or updated labeling to support product commercialization.
Collaboration and Guidance: Advise internal stakeholders (Clinical, Device Development, Legal, etc.) on current labeling requirements, tools, and Health Authority guidelines. Serve as the expert for device labeling on the global regulatory affairs team.
Lifecycle Management: Oversee the entire lifecycle management of labeling for PDT BU, including the development, approval, and submission of IFUs and other key labeling documents.
Innovative Solutions: Develop innovative strategies for labeling development and provide creative solutions to optimize data presentation and labeling content.
Cross-functional Engagement: Facilitate collaboration among internal teams to ensure labeling strategies align with regulatory requirements and product development needs.
Qualifications:
Experience: 4-7 years in the biopharmaceutical industry, with at least 3 years of direct experience in a global, US, or EU labeling role. Experience in plasma-derived therapies and biologics is preferred.
Education: Bachelor's or Master's degree required, with an advanced scientific or health sciences degree preferred.
Expertise: In-depth knowledge of pharmaceutical drug and device development and regulatory labeling requirements, including combination product/drug-device labeling.
Technical Skills: Proficiency in Electronic Document Management Systems and End-to-End Labeling Tracking Systems.
Benefits:
Competitive salary ranging from $133,000 to $209,000 annually.
Full benefits package including medical, dental, vision, 401(k) plan, short-term and long-term disability coverage, and paid time off.
About Takeda
Takeda is transforming patient care through innovative therapies and a collaborative workplace. We are certified as a Global Top Employer and are committed to fostering a diverse and inclusive environment for all employees.
Location:
Boston, MA
Employment Type:
Full-Time, Regular
Compensation:
Base Salary Range: $133,000 - $209,000
EEO Statement:
Takeda is an equal opportunity employer and embraces diversity in its workforce.
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