Global Labeling Strategist - Contract

JR United Kingdom; United Kingdom; Remote; GBP 60,000 - 100,000; Full time

Job summary

An established industry player in life sciences is seeking a Global Labeling Strategist to enhance regulatory affairs across diverse markets. This fully remote role allows you to shape global labeling strategies, ensuring compliance with regulatory documentation like CCDS and USPI. You'll collaborate with cross-functional teams, manage end-to-end labeling activities, and support health authority inquiries. If you're ready to make a strategic impact in a dynamic environment, this opportunity is perfect for you.

Qualifications

• Experience in regulatory labeling for major markets (e.g., US, EU).
• Solid understanding of global regulatory procedures and lifecycle management.

Responsibilities

• Develop and drive global labeling strategies aligned with regulatory objectives.
• Manage updates and compliance of CCDS, USPI, and SmPC for products.

Skills

Regulatory Labeling Experience

Project Management

Communication Skills

Attention to Detail

Understanding of GxP Requirements

Job description

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Client:

AL Solutions

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Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

02.05.2025

Expiry Date:

16.06.2025

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Job Description:

A leading life sciences company is seeking a Global Labeling Strategist to join its international Regulatory Affairs team. This position offers the opportunity to shape and manage global labeling strategies across a diverse portfolio, working with regulatory documentation such as the Company Core Data Sheet (CCDS), US Package Inserts (USPI), and EU Summary of Product Characteristics (SmPC).

This is a fully remote role, ideal for professionals looking to make a strategic impact in regulatory labeling across global markets.

Key Responsibilities:

• Develop and drive global labeling strategies in alignment with regulatory and product objectives.
• Manage updates and compliance of CCDS, USPI, and SmPC for products registered via Centralized, Mutual Recognition, or Decentralized Procedures.
• Serve as the primary point of contact for the Labeling Strategy Team (LST).
• Collaborate closely with cross-functional teams including Regulatory, Clinical, Medical, and Safety functions to ensure timely and compliant label updates.
• Coordinate and oversee end-to-end labeling activities and submission planning.
• Support responses to health authority inquiries and inspection-related labeling issues.
• Review country-specific labels to ensure accuracy and global consistency.

Candidate Requirements:

• Experience in regulatory labeling for at least one major market (e.g., US, EU).
• Solid understanding of global regulatory procedures, GxP requirements, and lifecycle management.
• Hands-on experience managing CCDS, SmPC, and USPI development and updates.
• Strong project management skills with experience in coordinating cross-functional teams.
• Excellent verbal and written communication abilities.
• Attention to detail and a thorough understanding of clinical and scientific documentation.
• Experience with global health authority submissions and queries.
• Ability to influence and guide internal stakeholders and subject matter experts.
• Familiarity with centralized and decentralized product registration processes.
• Prior experience working in a matrixed or global team environment.