Labeling Strategist (m/f/x) (Global Labeling Strategy Lead)

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3

Posted:

03.05.2025

Expiry Date:

17.06.2025

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Job Description:

Daiichi Sankyo, with over 120 years of experience and around 19,000 employees across more than 30 countries, is committed to advancing healthcare through innovative treatments. Our European headquarters are in Munich, Germany, and we operate in 15 European countries and Canada.

We are seeking highly qualified candidates for the position of:

The position:

This role serves as the GRA labeling expert within the Global Regulatory Team, providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads. It involves managing complex projects, maintaining global labeling documents, ensuring regulatory compliance, and collaborating across regions and functions. The position may be based in Europe, with options for on-site, hybrid, or remote work.

Key responsibilities include:

• Acting as the main contact for global labeling issues and supporting other Global Labeling Leads as needed.
• Managing and preparing regulatory documents such as USPI, EU SmPC, and CCDS.
• Leading discussions with FDA/CHMP and ensuring management alignment.
• Ensuring compliance with labeling regulations and guidelines, managing updates to Core Data Sheets, and overseeing labeling deviations.
• Conducting Label Review Committee Meetings and ensuring proper governance.
• Researching applicable health authority regulations and ensuring internal and external guideline compliance.
• Developing and reinforcing labeling best practices, SOPs, and process improvements.
• Building cross-functional and cross-regional relationships.

Qualifications include a Bachelor's degree in a scientific discipline (advanced degree preferred), at least 7 years of pharmaceutical industry experience, and 4+ years in regulatory affairs with EU/US labeling experience. Experience with CCDS and EU labeling is essential, with US labeling experience as a plus. Ability to travel up to 10% is required. Strong interpersonal skills and the ability to work independently and in teams are also necessary.