Global Labeling Strategist (Regulatory Studio )

JR United Kingdom; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

An innovative firm is seeking a Global Labeling Strategist to lead labeling updates and strategies in a remote role. This position involves collaboration with various teams to ensure compliance and timely submissions, making it essential for candidates to possess strong regulatory knowledge and excellent communication skills. The ideal candidate will have experience in managing projects and a solid understanding of drug development processes. Join this dynamic team and contribute to impactful labeling strategies that influence global health authorities.

Qualifications

• Expertise in labeling regulations and internal processes.
• Ability to manage medium-complexity projects effectively.

Responsibilities

• Drive labeling strategy in partnership with the Global Regulatory Team Leader.
• Collaborate with Global Regulatory Strategy and Clinical Development teams.

Skills

Labeling Strategy

Regulatory Knowledge

Communication Skills

Project Management

Attention to Detail

Job description

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Global Labeling Strategist (Regulatory Studio), United Kingdom

Client: Smartedge Solutions

Location: United Kingdom

Job Category: Other

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EU work permit required: Yes

Job Views:

3

Posted:

05.05.2025

Expiry Date:

19.06.2025

Job Description:

Smartedge’s client is seeking a Global Labeling Strategist (Regulatory Studio) for a remote position in the UK.

Experience Required:

• Accountability for labeling updates (CCDS, USPI, SmPC) for products registered via various procedures.
• Drive labeling strategy in partnership with the Global Regulatory Team Leader, providing expertise on labeling regulations, internal processes, and competitor analyses.
• Serve as primary contact for the Labeling Strategy Team (LST).
• Collaborate closely with TA counterparts in Global Regulatory Strategy, WWPS, Clinical Development, and Medical teams.
• Support timely and quality labeling submissions globally by coordinating activities of multifunctional contributors.
• Manage label review and approval processes, ensuring effective planning of cross-functional activities.
• Assist with responses to labeling inquiries from Global Health Authorities and during inspections.
• Review country labels for compliance.
• Possess basic knowledge of regulatory labeling and processes.
• Have labeling expertise in at least one major region and CCDS.
• Understand procedures, regulatory requirements, and GxP basics.
• Understand drug development and commercialization processes.
• Develop strong relationships across teams and influence diverse groups.
• Experience managing medium-complexity projects.
• Excellent communication skills, attention to detail, and ability to synthesize scientific information.

If interested or if you know someone suitable, please contact me at [phone].