Associate Director, Global Labeling Devices

Takeda; Boston (MA); Remote; USD 153,000 - 242,000; Full time

Job summary

An established industry player is seeking an Associate Director for Global Labeling Devices. This role is crucial in overseeing the development and maintenance of labeling documents, ensuring compliance with US and EU standards. You will lead cross-functional teams, manage labeling approvals, and contribute to continuous process improvements. With a focus on strategic thinking and leadership, this position offers a unique opportunity to impact the pharmaceutical landscape positively. Join a diverse and inclusive environment that values innovation and collaboration, where your expertise will drive transformative therapies globally.

Qualifications

• 8+ years in the pharmaceutical industry with at least 6 years in labeling or related regulatory experience.
• Deep knowledge of US and EU labeling regulations and guidelines.

Responsibilities

• Lead cross-functional labeling teams to develop and align labeling strategies.
• Manage local labeling exceptions and interactions with health authorities.
• Develop risk mitigation strategies and ensure labeling compliance.

Skills

US and EU labeling regulations

Strategic thinking

Communication skills

Analytical skills

Leadership

Risk management

Process optimization

Education

BSc degree

MSc, PhD, or PharmD

Job description

Associate Director, Global Labeling Devices

Join to apply for the Associate Director, Global Labeling Devices role at Takeda

This role offers a salary range of $153,600.00 to $241,340.00 per year, based on skills and experience. Your actual pay will be discussed with your recruiter.

Job Overview

At Takeda, we focus on innovative R&D to deliver transformative therapies globally. As Associate Director, you will oversee the development and maintenance of Instruction for Use (IFU) documents and device labeling in accordance with US and EU standards, ensuring compliance and strategic alignment across global teams.

Key Responsibilities

1. Lead cross-functional labeling teams to develop and align labeling strategies and content.
2. Coordinate with senior management and global teams to obtain labeling approvals.
3. Author and review labeling documents, incorporate new data, and manage communications related to labeling changes.
4. Manage local labeling exceptions and interactions with health authorities.
5. Develop risk mitigation strategies and ensure labeling compliance with regulatory requirements.
6. Conduct precedent searches and analyze labeling trends to maintain competitive and compliant labeling.
7. Represent Global Labeling Devices in various global regulatory and cross-functional teams.
8. Contribute to continuous process improvements in labeling workflows.

Minimum Qualifications

• BSc degree required; MSc, PhD, or PharmD preferred.
• 8+ years in the pharmaceutical industry, with at least 6 years in labeling or related regulatory experience.

Skills and Competencies

• Deep knowledge of US and EU labeling regulations and guidelines.
• Strong strategic thinking, communication, and analytical skills.
• Leadership ability to manage cross-functional teams and projects.
• Proactive in risk management and process optimization.

Additional Information

This position is remote, based in Massachusetts, and is classified as full-time, exempt employment. Takeda promotes diversity and equal opportunity and offers comprehensive benefits.