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

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

Zusammenfassung

An established industry player is seeking a GRA labeling expert to provide strategic and operational leadership on product labeling. This role involves managing regulatory documents, ensuring compliance, and collaborating across functions. The position offers flexibility in work location, allowing for on-site, hybrid, or remote arrangements. Ideal candidates will have extensive experience in regulatory affairs within the pharmaceutical industry, particularly with EU and US labeling. Join a forward-thinking organization committed to delivering innovative healthcare solutions across Europe and beyond.

Qualifikationen

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

Aufgaben

• Manage and prepare regulatory documents for labeling.
• Act as the point of contact for global labeling issues.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Cross-Functional Collaboration

Project Management

Interpersonal Skills

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree

Jobbeschreibung

The provided job description is comprehensive and detailed, but its formatting can be improved for better readability and engagement. The content is relevant and covers the responsibilities, qualifications, and other essential details effectively. However, the structure can be enhanced by better use of HTML tags to organize information clearly. Here is a refined version with improved formatting:

Job Details

Social network you want to login/join with: (not specified)

Client: (not specified)

Location: (not specified)

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 discovering and delivering innovative healthcare solutions worldwide. In Europe, our focus areas include:

• Cardiovascular Disease: Protecting people from the leading cause of death in Europe and helping patients enjoy life.
• Oncology: Driving innovation in solid tumors and blood cancers, based on 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:

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 serve as an ad hoc member of the Global Project Team to address labeling issues for late-stage projects and manages complex projects, including post-marketing and third-party development. Responsibilities include maintaining Company Core Data Sheets (CCDS), driving global labeling updates, ensuring regulatory compliance, and collaborating across functions and regions. The role offers flexibility in location across Europe, with options for on-site, hybrid, or remote work.

Key Responsibilities

• Act as the point of contact for global labeling issues across cross-functional teams.
• Manage and prepare regulatory documents such as USPI, labeling annotations, medication guides, EU SmPC, and CCDS.
• Lead discussions with FDA/CHMP, strategize for FDA meetings, and ensure management alignment.
• Ensure compliance with CCDS and manage updates, deviations, and labeling agreements.
• Coordinate Labeling Review Committee meetings, prepare review documents, and oversee governance.
• Research and ensure adherence to labeling regulations, guidelines, and internal processes.
• Develop and improve processes, SOPs, and best practices within the department.
• Build cross-regional relationships and collaborate with global teams.

Qualifications

• Bachelor's Degree in a scientific discipline; advanced degrees preferred.
• 7+ years in the pharmaceutical industry, with 4+ years in regulatory affairs, including 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.