Director, Global Regulatory Labeling Strategy

Job not on LinkedIn

November 1

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $174.5k - $274.2k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• 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. • Conducts precedent searches, analyzes relevant competitor labeling. • Represents Global Labeling at Global Regulatory Team (GRT). • Vendor Management Oversight and accountability for labeling activities. • Actively contributes to the continuous improvement of labeling processes.

🎯 Requirements

• BSc degree, preferred; BA accepted. • Advanced scientific degree (MSc, PhD, or PharmD) preferred. • 10+ years of pharmaceutical industry experience. • 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.

🏖️ Benefits

• U.S. based employees may be eligible for short-term and/or long-term incentives. • 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.