Senior Manager, Global Regulatory Labeling Strategy - Remote

Takeda • MA

126d • $137,000 - $215,270

About The Position

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).

Requirements

• BSc degree, preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 6+ years of pharmaceutical industry experience.
• 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.
• Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development.
• Ability to co-author, revise and/or update product labeling for regulatory submissions.

Nice To Haves

• Familiarity with other relevant regional regulatory nuances and requirements.
• Ability to identify factors and requirements necessary for regulatory recommendations.
• Ability to develop regulatory strategies based on regulatory requirements and competitive landscape.

Responsibilities

• 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.
• Assists in the development of labeling strategies and content for medium and/or high complexity products.
• Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (GLOC).
• Authors revised TLP, CCDS, USPI and/or EU SmPC for assigned products.
• Develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data.
• Authors/manages outgoing communications regarding significant labeling changes.
• Manages the process for alignment of local labeling with CCDS for assigned products.
• Proactively strengthen and foster robust relationships among functions represented at the Labeling cross functional teams.
• Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests.
• Represents Global Labeling at Global Regulatory Team (GRT).
• Supports Health Authority Inspections by providing labeling information requests related to assigned products.
• Assist in managing high complexity products by working with GLLs and labeling management.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and 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 calendar year
• Up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees