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

JR Germany; Baden-Baden; Hybrid; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Labeling Strategist to join their Global Regulatory Team. This role is pivotal in providing strategic leadership on product labeling, ensuring compliance with regulations while managing complex projects. You will collaborate with cross-functional teams, drive global labeling updates, and serve as a key point of contact for global labeling issues. The position offers flexibility with on-site, hybrid, or remote options, making it an exciting opportunity for those passionate about improving lives through innovative solutions. Join a dynamic team that values strategic decision-making and collaboration.

Qualifikationen

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

Aufgaben

• Lead cross-functional teams through labeling discussions with FDA/CHMP.
• Ensure compliance with CCDS and manage updates in US/EU labeling.

Kenntnisse

Regulatory Affairs

Labeling Development

Project Management

Interpersonal Skills

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree (Preferred)

Jobbeschreibung

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Labeling Strategist (m/f/x) (Global Labeling Strategy Lead), Baden-Baden

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Job Category: Other

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EU work permit required: Yes

Job Views:

2

Posted:

02.05.2025

Expiry Date:

16.06.2025

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 lives globally.

In Europe, our focus areas are:

• Specialty Business: Protecting against cardiovascular disease, the leading cause of death in Europe, and aiding patients suffering from it.
• Oncology: Innovating in 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 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 may involve serving as an ad hoc member of the Global Project Team for late-stage projects and managing complex projects, including post-marketing and third-party development. The role includes maintaining Company Core Data Sheets (CCDS), driving global labeling updates, ensuring regulatory compliance, and collaborating across functions and regions. The position often involves working with ambiguity and complex problems, focusing on strategic decisions.

This position can be based in Europe-wide locations, excluding Belgium and Greece, and can be on-site, hybrid, or remote. For more details on office locations, please visit our website.

• Act as a point of contact for cross-functional teams on global labeling issues.
• Assist other Global Labeling Leads with labeling development or approval for US or EU as 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 management alignment.
• Plan and strategize for FDA meetings as required.
• Ensure compliance with CCDS and manage updates and deviations in US/EU labeling.
• Lead Label Review Committee Meetings, preparing and reviewing documents for governance.
• Research and ensure compliance with labeling regulations from health authorities.
• Develop and improve processes and best practices, including SOPs.
• Build cross-regional relationships and coordinate with other departments.

Minimum Qualifications:

• Bachelor's Degree in a scientific discipline; advanced degree preferred.
• At least 7 years of experience in the pharmaceutical industry.
• Minimum of 4 years in regulatory affairs, including EU/US labeling experience.
• Experience with CCDS and EU labeling is essential; US labeling experience is a plus.
• Willingness to travel up to 10%.
• Strong interpersonal skills, ability to work independently and in teams.