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

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

Zusammenfassung

An established industry player is seeking a highly qualified Labeling Strategist to lead global labeling strategy within a dynamic regulatory team. This role involves managing complex projects, ensuring compliance with global regulations, and acting as the main contact for labeling issues across teams. The ideal candidate will possess extensive experience in regulatory affairs, particularly in the pharmaceutical industry, and will have a strong ability to build relationships and work collaboratively. Join this innovative firm and contribute to advancing healthcare through strategic labeling initiatives.

Qualifikationen

• 7+ years in the pharmaceutical industry, with 4+ years in regulatory affairs.
• Experience with CCDS and EU labeling; US labeling experience is a plus.

Aufgaben

• Manage regulatory documents like USPI, EU SmPC, PL, CCDS.
• Lead discussions with regulatory authorities like FDA and CHMP.

Kenntnisse

Regulatory Affairs

Labeling Strategy

Project Management

Interpersonal Skills

Ausbildung

Bachelor's degree in a scientific discipline

Advanced degree (preferred)

Jobbeschreibung

Social network you want to login/join with:

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

Client:

Location:

Job Category: Other

-

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 committed to advancing healthcare through innovative medicines. Our focus in Europe includes protecting people from cardiovascular diseases and pioneering cancer treatments, with headquarters in Munich and affiliates across Europe and Canada.

We are seeking a highly qualified Labeling Strategist (m/f/x) to serve as the GRA labeling expert within the Global Regulatory Team. This role involves strategic leadership on product labeling, managing complex projects, and ensuring compliance with global regulations. The position may be based anywhere in Europe (excluding Belgium and Greece), with options for on-site, hybrid, or remote work.

Key Responsibilities:

• Act as a point of contact for global labeling issues across cross-functional teams
• Manage and prepare regulatory documents such as USPI, EU SmPC, PL, CCDS
• Lead labeling discussions with regulatory authorities like FDA and CHMP
• Ensure compliance with all labeling regulations and guidelines
• Conduct Label Review Committee meetings and prepare necessary documentation
• Research and implement labeling regulations from health authorities
• Develop and improve labeling processes and SOPs
• Build cross-regional relationships and coordinate with external partners

Minimum Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 7+ years in the pharmaceutical industry with at least 4+ years in regulatory affairs, including 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 and ability to work independently and in teams