Global Labeling Strategist - Contract

AL Solutions; United Kingdom; Remote; GBP 50,000 - 90,000; Full time

Job summary

A leading life sciences company is seeking a Global Labeling Strategist to join its international Regulatory Affairs team. This fully remote role offers the chance to shape global labeling strategies across a diverse portfolio. You will manage regulatory documentation, ensuring compliance and accuracy, while collaborating with cross-functional teams. If you have a strong background in regulatory labeling and are looking to make a strategic impact, this opportunity is perfect for you. Join a forward-thinking organization where your expertise will drive success in global markets.

Qualifications

• Experience in regulatory labeling for major markets like US or EU.
• Strong project management skills and ability to coordinate teams.

Responsibilities

• Develop global labeling strategies in alignment with regulatory objectives.
• Manage updates and compliance of regulatory documents like CCDS and USPI.

Skills

Regulatory Labeling Experience

Project Management

Communication Skills

Attention to Detail

Understanding of GxP Requirements

Education

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Job description

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Expert in connecting top Regulatory Affairs & C-suite talent with Biotech, CRO, and Pharmaceutical clients across Europe and the US.

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Research

• Industries

  Research Services, Biotechnology Research, and Pharmaceutical Manufacturing

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