Senior Manager, Regulatory Affairs-Labeling

Takeda • Cambridge, MA

329d • $133,000 - $209,000

About The Position

The position involves assisting in the preparation, formatting, and quality control check of labeling documents such as the Company Core Data Sheet (CCDS), USPI, and SmPC for cross-functional team review, including post-GLOC endorsement. The role requires understanding the labeling regulatory strategy on the Global Regulatory Team (GRT) to ensure compliance with regulatory labeling requirements for assigned products. Responsibilities include managing the preparation and finalization of labeling activities, updating CCDS, and coordinating artwork in FOCUS, as well as managing change control in TrackWise. The position also involves tracking local exceptions and deferral requests in the submission tracking system.

Requirements

• BS Degree in a science discipline.
• 1-2 years of regulatory and/or related experience preferred.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Knowledge of global standards and regulations related to CCDS and Product Labeling.
• Strong oral and written communication skills.
• Ability to prioritize and manage multiple projects.
• Demonstrated problem-solving ability and strategic thinking.
• Strong interpersonal skills and cultural sensitivity.

Nice To Haves

• Advanced degree preferred.
• Pharmaceutical industry experience preferred.
• Experience with US PI and EU SmPC labeling.

Responsibilities

• Manage and track CCDS versions in the eDMS.
• Participate and provide advice at cross-functional labeling process discussions.
• Maintain updated metadata for all CCDS versions in the eDMS.
• Provide operational support for the preparation of the CCDS for cross-functional team review.
• Ensure formatting and quality control of the updated CCDS including post-GLOC endorsement.
• Prepare, format, and QC the USPI and SmPC labeling documents.
• Conduct consistency checks between CCDS and justification documents.
• Upload CCDS and justification documents to the eDMS.
• Coordinate with EU QPPV and Global Labeling Head for document approval.
• Maintain up-to-date labeling metadata for Vaccine products.
• Prepare and finalize events in the submission tracking system.
• Provide support to Local Affiliates for labeling activities.
• Participate in ad-hoc activities such as taking meeting minutes and document reviews.
• Liaise with US and EU Labeling Operations to meet labeling objectives and timelines.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per year.
• Up to 120 hours of paid vacation for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree