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

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

Zusammenfassung

An established industry player is looking for a Global Regulatory Affairs Labeling Expert to provide strategic leadership on product labeling. This exciting role involves managing complex regulatory projects, ensuring compliance with health authority regulations, and collaborating with cross-functional teams. With options for on-site, hybrid, or remote work, this position offers a unique opportunity to contribute to innovative healthcare solutions while working in a dynamic environment. If you have a strong background in regulatory affairs and a passion for improving labeling processes, this role is perfect for you.

Qualifikationen

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

Aufgaben

• Manage and prepare regulatory documents such as USPI and EU SmPC.
• Lead discussions with regulatory agencies like the FDA and CHMP.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Project Management

Interpersonal Skills

Ausbildung

Bachelor's Degree in 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 worldwide.

In Europe, our focus areas include:

• Protecting people from cardiovascular disease, the leading cause of death in Europe, and supporting patients affected by it.
• Driving innovation in oncology, particularly in solid tumors and blood cancers, based on groundbreaking 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:

Global Regulatory Affairs Labeling Expert

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 serve as an ad hoc member of the Global Project Team to address labeling issues for late-stage projects. Responsibilities include managing complex projects, maintaining Company Core Data Sheets (CCDS), leading global labeling efforts, ensuring compliance with regulations, and collaborating across functions and regions. The role can be based anywhere in Europe (excluding Belgium and Greece), with options for on-site, hybrid, or remote work. Please visit our website for office locations.

• Act as the point of contact for global labeling issues across cross-functional teams.
• Assist other Global Labeling Leads with labeling development and approval processes.
• Manage and prepare regulatory documents such as USPI, annotated labeling, medication guides, EU SmPC, and CCDS.
• Lead discussions with regulatory agencies like the FDA and CHMP, ensuring alignment and strategic planning.
• Ensure updates to Core Data Sheets and manage deviations from CCDS.
• Conduct Label Review Committee meetings and oversee governance processes.
• Research and ensure compliance with health authority labeling regulations.
• Develop and improve labeling processes and best practices, including SOPs.
• Build cross-regional relationships and collaborate with external partners.

Minimum qualifications include a Bachelor's degree in a scientific discipline (advanced degrees preferred), at least 7 years of pharmaceutical industry experience, with 4+ years in regulatory affairs and 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. Strong interpersonal skills and the ability to work independently and in teams are required.