Global Labelling Strategist

Job Title: Global Labelling Strategist

Location: Remote

Contract

Overview:

We are seeking an experienced Global Labelling Strategist to join our Global Regulatory Strategic Operations team, part of Global Regulatory and Safety Sciences. The ideal candidate will be responsible for driving global labelling strategies and managing the development, review, and maintenance of key labelling documents such as the Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Insert (USPI), and EU Summary of Product Characteristics (SmPC).

Key Skills:

Labelling | CCDS | SmPC | USPI | Regulatory Strategy | Global Submissions | Lifecycle Management

Key Responsibilities:

• Develop and execute global labelling strategies in partnership with the Global Regulatory Team Leader (GRTL), ensuring alignment with the overall regulatory and business strategy.

• Provide labelling expertise across CCDS, USPI, and SmPC (Centralized, Mutual Recognition, or Decentralized Procedure) for both Development and Lifecycle Management (LCM) projects.

• Act as the primary liaison for the Cross-Functional Labelling Team (CFLT) including GRTL, Medical Surveillance Team Lead (MSTL), functional SMEs, Documentation Leads, Medical Writers, Dossier Leads, and Submission Managers.

• Coordinate labelling activities among multifunctional teams, ensuring efficient review, approval, and implementation processes.

• Oversee planning and execution of all cross-functional labelling activities to ensure timely and quality submissions.

• Support responses to global health authority inquiries and inspection activities related to labelling.

• Review country-specific labels to maintain compliance with global standards and regulatory requirements.

• Mentor and provide training for other Global Labelling Leads as needed.

• Lead or contribute to process improvement initiatives and the development of tools and technologies to streamline labelling operations.

• Identify opportunities to influence regulatory policies and contribute to shaping global labelling standards and practices.

Required Qualifications:

• Master’s degree in Life Sciences or equivalent with at least 5 years of labelling experience (CCDS / USPI / SmPC),
  OR
  Bachelor’s degree in Life Sciences with at least 7 years of labelling or regulatory experience.

Desired Skills and Experience:

• Strong understanding of global labelling guidelines, drug development, and commercialization of prescription medicines.

• In-depth knowledge of Company Core Data Sheets (CCDS) and their regulatory implications.

• Proven ability to interpret and apply regulatory requirements to labelling content and strategy.

• Excellent communication, collaboration, and organizational skills with the ability to work cross-functionally in a global environment.

• Strong analytical and problem-solving abilities with attention to detail and quality.

All your information will be kept confidential according to EEO guidelines.