Associate Director, Global Labeling Lead

Takeda

8d • 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 Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance.

Requirements

• BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
• Knowledge of US and/or EU regulatory requirements and guidelines.
• Knowledge of other relevant regional regulatory nuances and requirements.
• Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
• Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance.
• Ability to develop target labeling profile (TLP) with minimal supervision and guidance.
• Understanding of the broad concepts within global labeling and implications across the organization and globally.
• Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.

Responsibilities

• Management of Labeling Cross-Functional Teams
• Interface with Senior Management Cross-Functional Team (GLOC)
• Labeling Documents Authoring, Submission, and Labeling Negotiations
• Management of Local Exceptions and LOC Interactions
• Escalation Process and Stakeholder Management
• Precedent Search and Labeling Trends
• Working within Labeling Team and GRA
• Vendor Management
• Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
• Continuous Improvement
• Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees