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

JR Germany; Lübeck; 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 pivotal role involves providing strategic leadership on product labeling while ensuring compliance with regulations across multiple regions. The ideal candidate will have extensive experience in regulatory affairs, particularly in EU and US labeling, and will thrive in a dynamic environment that requires strong interpersonal skills and teamwork. This opportunity offers flexibility in work arrangements, allowing you to contribute to innovative healthcare solutions from various locations in Europe.

Qualifikationen

• 7+ years of pharmaceutical industry experience, including 4+ years in regulatory affairs.
• Experience with CCDS and EU labeling is essential.

Aufgaben

• Act as the point of contact for global labeling issues across teams.
• Manage updates to Core Data Sheets and labeling deviations.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Project Management

Interpersonal Skills

Teamwork

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree (Preferred)

Tools

Regulatory Document Management

Jobbeschreibung

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Job Views:

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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 to improve lives worldwide.

In Europe, our focus areas include:

• Protecting people from cardiovascular disease, the leading cause of death in Europe, and supporting patients suffering from it.
• Driving innovation in oncology, focusing on solid tumors and blood cancers, based on breakthrough science from our labs in 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:

Position:

This role serves as the GRA labeling expert within the Global Regulatory Team (GRT), providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). It may also involve addressing labeling issues for late-stage projects as part of the Global Project Team (GPT). The role includes managing complex projects, including post-marketing and third-party development projects, and maintaining the Company Core Data Sheets (CCDS) for assigned products.

The position involves driving global labeling maintenance, ensuring compliance with regulations, and interacting across functions and regions. It requires working with ambiguity and complex issues, focusing on strategic decisions.

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

• Act as the point of contact for global labeling issues across teams.
• Assist other Global Labeling Leads with labeling development or approval for US or EU when needed.
• Manage and prepare regulatory documents such as USPI, annotated labeling, medication guides, EU SmPC, PL, and CCDS.
• Lead cross-functional teams through labeling discussions with FDA/CHMP, ensuring alignment and strategizing for meetings.
• Manage updates to Core Data Sheets and labeling deviations, ensuring compliance with CCDS and licensing agreements.
• Prepare documents for Label Review Committee meetings and lead review processes, ensuring governance.
• Research and ensure compliance with applicable health authority labeling regulations and guidelines.
• Develop and reinforce labeling best practices, SOPs, and process improvements.
• Build cross-functional and cross-regional relationships.

Minimum qualifications include a Bachelor's Degree in a scientific discipline (advanced degree preferred), at least 7 years of pharmaceutical industry experience, with 4+ years in regulatory affairs, including EU/US labeling experience. Relevant experience with CCDS and EU labeling is essential, with US labeling experience a plus. The role may require up to 10% travel. Strong interpersonal skills, independence, and teamwork abilities are necessary.