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Manager, Global Labeling Compliance and Operations-Remote Eligible

Vertex

London

Remote

GBP 60,000 - 90,000

Full time

Today
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Job summary

A leading company in pharmaceuticals is seeking a Manager of Labeling Compliance and Operations in London. The role demands expertise in regulatory compliance, effective communication with a focus on ROW markets, and experience in pharmaceutical labeling. The candidate will lead cross-functional teams and manage critical labeling processes to ensure adherence to compliance standards.

Qualifications

  • Extensive experience in pharmaceutical industry, especially in regulatory project management.
  • Proficiency in leading process improvements and managing multiple projects.
  • Experience with Quality Management Systems and CAPA management.

Responsibilities

  • Support development and maintenance of regulatory labeling priorities for ROW markets.
  • Manage creation, review, and approval of packaging and labeling.
  • Oversee compliance with global and regional labeling processes.

Skills

Pharmaceutical regulations
Planning
Analytical skills
Communication skills
Leadership

Education

Bachelor’s degree in life sciences

Tools

Electronic document management systems
RIM management system
Label tracking tools

Job description

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Manager, Global Labeling Compliance and Operations-Remote Eligible, London

Client:

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: c0b8520394ea

Expiry Date: 06.08.2025

Job Description:

Position Summary:

The Global Labeling Team at Vertex is seeking a highly motivated Manager of Labeling Compliance and Operations - Rest of World (ROW). The candidate should understand global labeling and ensure compliance with regulatory requirements and processes. Responsibilities include supporting inspection readiness, managing regional product labeling, reviewing packaging artwork, and liaising with stakeholders in commercial and supply chain.

The candidate will develop strong matrixed relationships and support the Regional Labeling Lead in collaboration with global regulatory affairs and cross-functional teams to develop labeling strategies. The role requires a proactive individual capable of leading, influencing, and collaborating effectively.

Key Responsibilities:

  • Support the Regional Labeling Lead in developing and maintaining regulatory labeling priorities for ROW markets.
  • Collaborate on artwork and stakeholder requirements for new markets.
  • Manage creation, review, and approval of packaging and labeling for ROW.
  • Draft regulatory responses for package component labeling in ROW countries.
  • Coordinate label changes with stakeholders.
  • Assess regulatory impact of label changes.
  • Manage deviations and CAPAs related to labeling in ROW.
  • Support development and archiving of regional product labeling documents.
  • Communicate approved labeling to ROW markets.
  • Perform proofreading and QC tasks as needed.

Department Operations:

  • Coordinate with vendors for translation and other labeling support.
  • Manage projects to improve processes, including SOP and WI updates.

Compliance:

  • Oversee compliance with global and regional labeling processes.
  • Track updates and deviations, maintain records.

This position reports to the Global Head of Regulatory Labeling Compliance and Operations, GRA.

Skills/Experience:

  • Knowledge of pharmaceutical regulations, especially labeling and packaging.
  • Strong planning, organizational, analytical, proofreading, and decision-making skills.
  • Experience leading process improvements and managing multiple projects.
  • Leadership and motivational abilities.
  • Independent judgment and decision-making skills.
  • Excellent communication skills.
  • Proficiency with electronic document management systems.
  • Experience with pharmaceutical labeling regulations in ROW markets, especially Middle East, Asia, and Balkans, is desirable.
  • Experience with Quality Management Systems, change control, deviation, and CAPA management.
  • Familiarity with RIM management system and label tracking tools is desirable.
  • Bachelor’s degree in a life sciences field preferred, with higher degrees advantageous.
  • Extensive experience in the pharmaceutical industry in regulatory project management, labeling development, or related areas.
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