Associate Director, Global Labeling Devices

Takeda Pharmaceutical Company • Agawam, MA

271d • $153,600 - $241,340 • 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. As Associate Director, Global Labeling Devices, you will be responsible for the development, maintenance, and implementation of Instruction for Use (IFU) documents and Device Container Labeling content in line with US and EU standards and guidelines. Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team (GDT) to ensure that regulatory device labeling requirements are met for assigned products.

Requirements

• BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
• Strong knowledge of US and EU IFU product labeling requirements, regulations, and guidelines.
• Ability to develop & execute clear and practical regulatory strategies.
• Strong analytical and problem-solving skills.
• Ability to effectively collaborate with global cross-functional teams.
• Demonstrates project management skills and ability to independently deliver accurate and complete work.

Nice To Haves

• Knowledge of other relevant regional regulatory nuances and requirements.
• Understanding of the broad concepts within global labeling and implications across the organization.

Responsibilities

• Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content for the Information For Use (IFU) and key global labeling documents.
• Collaborates cross-functionally to provide input into Clinical IFU, design input requirements, quality system required documentation, human factors strategy, and regulatory strategy.
• Coordinates the process to obtain IFU labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC).
• Authors new/revised IFU content for the 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.
• Independently authors/manages outgoing communications regarding significant labeling changes for assigned products.
• Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission.
• Manages process for alignment of local labeling with IFU for assigned products.
• Provides support to Local Affiliates for responses to health authorities requests.
• Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL).
• Conducts precedent analysis and develops strategies and labeling language for assigned product labels.
• Represents Global Labeling Devices at Global Regulatory Team (GRT).
• 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