Global Labelling Lead
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Job Description
Global Labelling Lead guiding pharmaceutical labeling strategy and regulatory compliance at ICON, a global healthcare intelligence and clinical research organisation. Managing labeling documents and cross-functional regulatory activities.
Responsibilities:
- Oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations
- Develop and implement regulatory labeling strategies for drug development projects
- Ensure compliance with global regulatory requirements and standards related to labeling
- Manage the creation, review, and approval of labeling documents, including package inserts, patient leaflets, and labels
- Coordinate labeling activities with cross-functional teams, including regulatory affairs, clinical development, and quality assurance
- Provide regulatory guidance and assist internal teams and external clients on labeling-related issues
Requirements:
- Bachelor's degree in a scientific discipline or related field
- Minimum of 8 years of experience in regulatory affairs or labeling within the pharmaceutical or biotechnology industry
- Strong understanding of global regulatory requirements and guidelines related to labeling
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively in a fast-paced environment
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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