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

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

Zusammenfassung

An established industry player is looking for a GRA labeling expert to join their Global Regulatory Team. This role offers an exciting opportunity to lead strategic initiatives in product labeling while ensuring compliance with regulations. You will manage complex projects and collaborate with cross-functional teams to drive best practices in labeling. With a focus on cardiovascular and oncology products, this position allows you to make a significant impact on patient care across Europe. If you have extensive experience in regulatory affairs and a passion for innovation, this is the perfect opportunity for you.

Qualifikationen

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

Aufgaben

• Manage and prepare regulatory documents such as USPI and labeling.
• Lead discussions with FDA/CHMP and ensure alignment with management.
• Conduct Label Review Committee meetings and oversee governance processes.

Kenntnisse

Regulatory Affairs

Project Management

Labeling Compliance

Interpersonal Skills

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree (Preferred)

Jobbeschreibung

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Job Description:

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

We are seeking highly qualified candidates to fill the position of:

The Position:

This role serves as the GRA labeling expert to the Global Regulatory Team (GRT), providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). Responsibilities include managing complex projects, maintaining Company Core Data Sheets (CCDS), and ensuring compliance with regulations. The position involves interaction across global RA functions and regional areas, often working with ambiguity and complex issues.

This role can be based anywhere in Europe (excluding Belgium and Greece), on-site, hybrid, or remote. Please visit our website for more information on office locations.

Key Responsibilities:

• Act as the point of contact for global labeling issues within cross-functional teams.
• Manage and prepare regulatory documents such as USPI, labeling, medication guides, EU SmPC, and CCDS.
• Lead discussions with FDA/CHMP, strategize for meetings, and ensure alignment with management.
• Ensure updates to CCDS and manage deviations from labeling standards.
• Conduct Label Review Committee meetings, prepare documentation, and oversee governance processes.
• Research and ensure compliance with health authority labeling regulations.
• Develop and reinforce labeling best practices, SOPs, and process improvements.
• Build cross-regional relationships and collaborate with global teams.

Minimum Qualifications:

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