Senior Manager, Global Labeling Strategy

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

Job summary

An established industry player is seeking a Senior Manager for Global Labeling Strategy. This pivotal role involves ensuring timely updates to critical labeling documents and collaborating with cross-functional teams to align regulatory objectives. The ideal candidate will possess a solid understanding of global labeling regulations and demonstrate expertise in major markets. This position offers the opportunity to lead strategic initiatives, manage complex projects, and drive high-quality outputs in a dynamic environment. If you're a proactive problem-solver with exceptional communication skills, this is the perfect opportunity to make a significant impact.

Qualifications

• Solid understanding of global labeling regulations and processes.
• Proven ability to manage labeling strategies aligning with regulatory objectives.

Responsibilities

• Lead labeling strategy in collaboration with the Global Regulatory Team.
• Oversee labeling review processes to ensure compliance and efficiency.

Skills

Global Labeling Regulations

CCDS Management

GxP Principles

Drug Development Knowledge

Project Management

Collaboration Skills

Leadership Skills

Communication Skills

Job description

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Senior Manager, Global Labeling Strategy, united kingdom

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Client:

G&L Scientific

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

6

Posted:

26.04.2025

Expiry Date:

10.06.2025

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Job Description:

Overview:

The Senior Manager, Global Labeling Strategy is responsible for ensuring timely and accurate updates to key labeling documents, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI), and European Summary of Product Characteristics (SmPC) for products approved via the Centralized, Mutual Recognition, or Decentralized Procedures.

Key Responsibilities:

• Lead labeling strategy in collaboration with the Global Regulatory Team Leader, aligning with overall regulatory objectives and providing subject matter expertise on global labeling regulations, processes, and competitive intelligence.
• Act as the primary point of contact for the Labeling Strategy Team (LST).
• Partner cross-functionally with stakeholders in Regulatory Strategy, Safety, Clinical Development, and Medical Affairs to support labeling content development and review.
• Serve as the key interface with Country Regulatory Managers to ensure global alignment and timely submission of labeling updates.
• Oversee cross-functional labeling review and approval processes to drive high-quality, compliant, and efficient outputs.
• Coordinate planning and execution of all labeling-related activities across global teams.
• Support responses to Health Authority inquiries and inspection-related labeling requests.
• Review country-specific labels to ensure alignment with global labeling and regulatory standards.

Qualifications:

• Solid understanding of global labeling regulations, requirements, and processes.
• Demonstrated expertise in at least one major market (e.g., US, EU) and experience with CCDS management.
• Familiarity with GxP principles and regulatory procedures across the product lifecycle.
• Strong knowledge of drug development and commercialization pathways.
• Proven ability to assess and manage labeling strategies in alignment with regulatory and business objectives.
• Excellent collaboration skills with the ability to build relationships across cross-functional and global teams.
• Strong leadership, facilitation, and decision-making skills, especially within multidisciplinary environments.
• Project management experience, particularly with moderately complex initiatives.
• Exceptional written and verbal communication skills.
• High attention to detail and ability to synthesize complex scientific and clinical information.
• Creative problem-solver with a proactive and solutions-oriented mindset.