Associate Director (Global Labeling Lead) Remote

                                           Associate Director, Global Labeling Lead - Remote - Be a Labeling Visionary!

Are you a seasoned labeling expert seeking a high-impact, fully remote role with a global leader in pharmaceuticals? This is your chance to join a cutting-edge company and contribute to the development of life-changing therapies. As an Associate Director, Global Labeling Lead, you will play a pivotal role in shaping the future of patient care.

https://sojobs.short.gy/TekedaDirector (This link contains full details about the company, compensation, and benefits.)

What Makes This Opportunity Truly Exceptional?

• Influence Global Healthcare: Directly impact patient safety and access to vital medications by leading the development and implementation of global labeling strategies.
• Work on Transformative Therapies: Contribute to the development of innovative specialty pharmaceuticals and best-in-class patient support programs.
• Lead Cross-Functional Teams: Collaborate with internal and external stakeholders, including senior management and health authorities, to achieve labeling alignment and regulatory success.
• Fully Remote Flexibility: Embrace the work-life balance and autonomy of a fully remote position, allowing you to work from anywhere.
• Be Part of a Leading Company:

   

  Join a globally recognized pharmaceutical company committed to transforming patient care and fostering a culture of innovation and collaboration.

How You Will Contribute:

• Lead and manage Labeling Cross-Functional Teams, driving collaboration and consensus.
• Interface with the Senior Management Cross-Functional Team (GLOC) to secure labeling approvals.
• Author and manage key labeling documents (TLP, CCDS, USPI, EU SmPC), incorporating new data and regulatory feedback.
• Develop and execute labeling implementation plans.
• Manage communications regarding labeling changes.
• Coordinate global labeling activities and ensure timely submissions to health authorities.
• Lead or participate in label negotiations with health authorities.
• Interpret and apply labeling regulations and guidelines.
• Manage local labeling exceptions and interactions with local affiliates.
• Escalate issues and propose risk mitigation strategies.
• Conduct precedent searches and analyze labeling trends.
• Represent Global Labeling at the Global Regulatory Team (GRT).
• Liaise with labeling operations and other relevant teams.
• Support health authority inspections.
• Manage external vendors for labeling activities.
• Contribute to continuous improvement of labeling processes.

Minimum Requirements/Qualifications:

• BSc degree (preferred), BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 8 years of pharmaceutical industry experience, 1 including 6 years of labeling experience or a combination of 5 years regulatory and/or related experience.  

  1. jobs.takeda.com

  jobs.takeda.com

• Strong knowledge of US and EU labeling requirements.
• Knowledge of other regional regulatory nuances.
• Knowledge of scientific principles and regulatory systems.
• Ability to create and update product labeling.
• Ability to develop target labeling profiles.
• Understanding of global labeling concepts.
• Knowledge of health authority audit processes.

Compensation and Benefits:

A competitive compensation and benefits package is offered. (Specific details will be discussed with qualified candidates.)

Ready to Be a Labeling Visionary?

Apply Now!

• https://sojobs.short.gy/TekedaDirector (This link contains full details about the company, compensation, and benefits.)

Have Questions? Let's Connect!

I'm here to help:

• Email: Joey@sohealthtalent.com
• Phone: (931) 343-6490 | ext 1002

Schedule a Chat:

Ready to discuss this opportunity further? Schedule a time to connect, and I'll call you if you're qualified:

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