Hays
Global Labelling Lead - Regulatory Affairs
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Global Labelling Lead, Regulatory Affairs, Hybrid Working, Contract Job
Your New Company
We are currently seeking an experienced Global Labelling Lead to join a leading global biopharmaceutical organisation on a contract basis. This is an exciting opportunity for a regulatory professional with strong labelling expertise to take ownership of global labelling strategy and influence the safe and effective use of medicines worldwide.
Your New Role
As the Global Labelling Lead, you will be responsible for leading the development, maintenance, and implementation of core labelling documents across the product life cycle. Working within a highly collaborative global environment, you will partner with cross-functional stakeholders to ensure labelling remains compliant, competitive, and aligned with global regulatory requirements.
Key Responsibilities
Global Labelling Strategy & Content Development
- Lead the development and maintenance of global core labelling documents, including Company Core Data Sheets (CDS), Global Patient Leaflets, and Target Label Profiles.
- Define and drive labelling strategy in alignment with global regulatory objectives and product development plans.
- Chair and lead cross-functional Global Labelling Teams, facilitating consensus and securing senior leadership endorsement on key labelling decisions.
- Ensure labelling content remains accurate, compliant, and aligned with emerging clinical and regulatory data.
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Regional Implementation & Compliance
- Oversee the implementation of CDS updates across regional and local markets.
- Monitor compliance with global labelling processes and standards.
- Support regional regulatory teams in responding to health authority labelling queries.
- Identify, track, and manage country-specific labelling differences.
Regulatory Documentation & Governance
- Oversee the preparation of supporting documentation for labelling changes in partnership with Medical Writing and cross-functional teams.
- Maintain robust version control and tracking of labelling implementation within regulatory systems.
- Contribute to the development and continuous improvement of labelling procedures, SOPs, and governance processes.
- Provide support during audits and regulatory inspections.
Stakeholder Leadership
- Act as the subject matter expert for global labelling activities.
- Deliver training and guidance to internal stakeholders and new team members.
- Collaborate closely with Regulatory Affairs, Clinical Development, Safety, Medical Writing, and Commercial teams to ensure labelling supports both patient safety and business objectives.
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What You'll Need to Succeed
- Substantial experience of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Proven experience in global regulatory labelling.
- Strong understanding of labelling regulations, processes, and life cycle management.
- Experience using document management systems and regulatory tracking tools.
- Excellent project management and organisational skills.
- Ability to influence and collaborate effectively across global, cross-functional teams.
- Strong written and verbal communication skills.
- Experience working within a multinational or multicultural environment.
What You'll Get in Return
- Flexible working environment
- Competitive rates of pay
What You Need to Do Now
If you are an experienced Regulatory Labelling professional looking for your next contract opportunity within a global pharmaceutical environment, we would love to hear from you.
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