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

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

Zusammenfassung

An established industry player seeks a GRA labeling expert to join their Global Regulatory Team. This role offers the opportunity to lead strategic and operational initiatives in product labeling, ensuring compliance with regulations while managing complex projects across regions. The ideal candidate will have extensive experience in regulatory affairs, particularly in EU/US labeling, and will thrive in a dynamic environment. With the flexibility to work on-site, hybrid, or remotely, this position promises to be both challenging and rewarding, contributing to the improvement of patient care through innovative solutions.

Qualifikationen

• 7+ years of experience in the pharmaceutical industry, with 4+ years in regulatory affairs.
• Experience with CCDS and EU labeling is essential; US labeling experience is a plus.

Aufgaben

• Lead cross-functional teams through labeling discussions with FDA/CHMP.
• Prepare and manage regulatory documents such as USPI and EU SmPC.
• Ensure compliance with health authority labeling regulations.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Project Management

Interpersonal Skills

Strategic Decision Making

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree (Preferred)

Tools

Regulatory Document Management

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 new standards of care to improve quality of life worldwide.

In Europe, our focus areas are:

• Protecting people from cardiovascular disease, the leading cause of death in Europe, and helping patients enjoy life.
• Driving innovation in oncology, including solid tumours 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 seek highly qualified candidates for the position of:

Position:

The role serves as the GRA labeling expert within the Global Regulatory Team (GRT), providing strategic and operational leadership on product labeling. It may involve serving on Global Project Teams (GPT) for late-stage projects and managing complex projects, including post-marketing and third-party development. The role collaborates with Global Regulatory Leads (GRLs) and Clinical Safety Pharmacovigilance (CSPV) leads to maintain Company Core Data Sheets (CCDS) and drives global labeling updates for Daiichi Sankyo products. Ensuring compliance with regulations and guidelines, managing deviations, and interacting across functions and regions are key responsibilities. The position often involves working with ambiguity and complex issues, focusing on strategic decisions.

This role can be based anywhere in Europe (excluding Belgium and Greece), on-site, hybrid, or remote. More information about office locations can be found on our website.

• Act as the point of contact for global labeling issues with cross-functional teams.
• Assist other Global Labeling Leads as needed, managing labeling development or approval in the US or EU.
• Prepare and manage 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.
• Plan and strategize for FDA meetings.
• Ensure updates to Core Data Sheets and manage deviations from CCDS across US/EU and local countries.
• Conduct Label Review Committee meetings, preparing documents and leading review processes.
• Research and ensure compliance with health authority labeling regulations.
• Develop and reinforce labeling best practices and SOPs, and collaborate with global teams to produce 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, with 4+ years in regulatory affairs, including EU/US labeling. Experience with CCDS and EU labeling is essential; US labeling experience is a plus. The role may require up to 10% travel, and strong interpersonal skills, independence, and teamwork are necessary.