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

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

Zusammenfassung

An innovative firm is seeking a GRA labeling expert to join their Global Regulatory Team. This exciting role involves managing complex labeling projects and ensuring compliance with regulations across various regions. The successful candidate will collaborate with cross-functional teams and lead discussions with health authorities. With a focus on strategic decision-making and operational leadership, this position offers the flexibility to work remotely or on-site anywhere in Europe. If you have a strong background in regulatory affairs and a passion for improving healthcare solutions, this is a fantastic opportunity to make a significant impact.

Qualifikationen

• 7+ years in the pharmaceutical industry with 4+ years in regulatory affairs.
• Experience with CCDS and EU labeling, strong project management skills.

Aufgaben

• Manage labeling development or approval for US or EU.
• Act as the point of contact for cross-functional teams on global labeling issues.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Project Management

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, developing, and delivering innovative healthcare solutions that 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 located 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 also participate as an ad hoc member of the Global Project Team to address labeling issues for late-stage projects. It involves managing complex projects, including post-marketing and third-party development, and partnering with CSPV leads in maintaining the Company Core Data Sheets. The role drives global labeling maintenance, ensuring compliance with regulations and guidelines, and interacts across global and regional functions. The position often involves working with ambiguity and complex problems, focusing on strategic and operational 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 point of contact for cross-functional teams on global labeling issues.
• Manage labeling development or approval for US or EU, depending on timelines and resources.
• Prepare and implement regulatory documents such as USPI, annotated labeling, medication guides, EU SmPC, PL, and CCDS.
• Lead cross-functional discussions with FDA/CHMP and ensure management alignment.
• Plan for FDA meetings as needed.
• Ensure updates to Core Data Sheets and manage deviations from CCDS.
• 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 reinforce labeling best practices, SOPs, and process improvements.
• Build cross-regional relationships and coordinate with external partners.

Qualifications include a Bachelor's Degree in a scientific discipline (advanced degree preferred), 7+ years in the pharmaceutical industry, with 4+ years in regulatory affairs, including EU/US labeling experience, and relevant experience with CCDS and EU labeling. Ability to travel up to 10% and strong interpersonal skills are required.