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

JR Germany; Bremen; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

An innovative healthcare company is on the lookout for a GRA labeling expert to join their Global Regulatory Team. This role involves providing strategic leadership on product labeling while ensuring compliance with regulations across various jurisdictions. You will manage complex projects, collaborate with cross-functional teams, and lead discussions with regulatory bodies. This position offers flexibility in working arrangements, including onsite, hybrid, or remote options, making it an exciting opportunity for professionals passionate about advancing healthcare solutions.

Qualifikationen

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

Aufgaben

• Primary contact for global labeling issues across teams.
• Manage regulatory documents like USPI and CCDS.

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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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 developing innovative healthcare solutions worldwide.

In Europe, our focus is on two main areas: protecting people from cardiovascular disease through our Specialty Business, and advancing cancer treatment in Oncology, driven by 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). The role may involve serving on Global Project Teams to address labeling issues for late-stage projects, managing complex projects including post-marketing and third-party development, and maintaining Company Core Data Sheets (CCDS) for assigned products. It also involves leading the maintenance of global labeling documentation, ensuring compliance with regulations and guidelines, and collaborating across functions and regions. The position may be based anywhere in Europe (excluding Belgium and Greece), working onsite, hybrid, or remotely.

The key responsibilities include:

• Acting as the primary contact for global labeling issues across cross-functional teams.
• Managing and preparing regulatory documents such as USPI, labeling, medication guides, EU SmPC, PL, and CCDS.
• Leading discussions with the FDA/CHMP and preparing for regulatory meetings.
• Ensuring updates to Core Data Sheets and managing deviations from CCDS.
• Conducting Label Review Committee Meetings and ensuring governance.
• Researching and ensuring compliance with labeling regulations in various jurisdictions.
• Developing and improving labeling processes and best practices, including SOPs.
• Building cross-regional relationships and coordinating with external partners.

Qualifications include:

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