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

JR Germany; Mönchengladbach; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a GRA labeling expert to join their Global Regulatory Team. This exciting role involves leading strategic labeling initiatives, ensuring compliance with EU and US regulations, and collaborating with cross-functional teams. Candidates should possess a strong background in regulatory affairs, with at least 7 years in the pharmaceutical sector and a Bachelor's degree in a scientific discipline. The position offers flexibility in work location—be it on-site, hybrid, or remote—allowing you to contribute to innovative healthcare solutions across Europe. If you are passionate about improving patient outcomes through effective labeling strategies, this opportunity is perfect for you.

Qualifikationen

• 7+ years of experience in the pharmaceutical industry with a focus on regulatory affairs.
• Expertise in EU/US labeling and CCDS management.

Aufgaben

• Lead global labeling projects and ensure compliance with regulations.
• Act as primary contact for cross-functional teams on labeling issues.
• Prepare and implement regulatory documents for product labeling.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Project Management

Cross-Functional Collaboration

Interpersonal Skills

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree (Preferred)

Jobbeschreibung

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Posted:

02.05.2025

Expiry Date:

16.06.2025

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Job Description:

Daiichi Sankyo, with over 120 years of experience and approximately 19,000 employees across more than 30 countries, is dedicated to discovering and delivering innovative healthcare solutions. In Europe, our focus areas include:

• Cardiovascular Disease: Protecting people from the leading cause of death in Europe and helping patients enjoy life.
• Oncology: Driving innovation in solid tumors and blood cancers, based on breakthrough science from Japan.

Our European headquarters are in Munich, Germany, with affiliates 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. The position may involve serving on Global Project Teams to address labeling issues for late-stage projects, managing complex projects including post-marketing and third-party development, and maintaining Company Core Data Sheets (CCDS). The role involves leading the maintenance of global labeling documents, ensuring compliance with regulations, and collaborating across regions and functions. The position often involves working with ambiguity and complex problems, focusing on strategic decisions.

This role can be based anywhere in Europe (excluding Belgium and Greece), on-site, hybrid, or remote. For more information on office locations, please visit our website.

• Act as the primary contact for cross-functional teams on global labeling issues.
• Assist other Global Labeling Leads with managing labeling development or approval processes.
• Prepare and implement regulatory documents such as USPI, labeling annotations, medication guides, EU SmPC, PL, and CCDS.
• Lead cross-functional discussions with FDA/CHMP, ensuring alignment and strategic planning for meetings.
• Manage updates to Core Data Sheets and ensure compliance with labeling regulations and guidelines.
• Conduct Label Review Committee meetings, preparing documents and leading review processes.
• Research applicable health authority labeling regulations and ensure compliance with internal and external guidelines.
• Develop and improve processes and best practices, including SOPs.
• Build cross-regional relationships and coordinate with various teams to ensure high-quality labeling documentation.

Minimum qualifications include a Bachelor's Degree in a scientific discipline (advanced degree preferred), at least 7 years of pharmaceutical industry experience, and 4 or more years of direct regulatory affairs experience with EU/US labeling. Relevant experience with CCDS and EU labeling is essential, with US labeling experience as a plus. Ability to travel up to 10% and strong interpersonal skills are required.