Director, Global Regulatory Labeling Strategy

Takeda Pharmaceutical Company • Agawam, MA

269d • $174,500 - $274,230 • Remote

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 Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.

Requirements

• BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 10+ years of pharmaceutical industry experience, including 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.
• Ability to develop & execute clear and practical regulatory strategies.
• Strong understanding of the core business aspect.
• Ability to effectively collaborate with global cross-functional teams.
• Demonstrates deep understanding of analytical methodologies and problem-solving techniques.
• In-depth expertise of US and EU product labeling requirements, regulations, and guidelines.
• Strong understanding of global labeling processes and implications across the organization.

Responsibilities

• Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content.
• Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC).
• Independently authors new/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.
• Manages process for alignment of local labeling with CCDS for assigned products.
• Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL).
• Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests.
• Represents Global Labeling at Global Regulatory Team (GRT).
• Effectively manages resources and staff to ensure optimal performance.
• Oversight and accountability for labeling activities managed by external vendor(s).
• Actively contributes to the continuous improvement of labeling processes.

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
• Accrual of up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree