Global Labeling Strategist - Contract

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.

Desirable Skills:

• 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.