Cpl Life Sciences
Regulatory Affairs Manager, Global Labeling Compliance & Operations
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Regulatory Affairs Manager, Global Labeling Compliance & Operations
Location: UK, Remote
20 Hours per Week
Rate: £30 - £35 per hour PAYE
12 Month Contract – PAYE
Department: Global Regulatory Sciences (GRS) – Global Labeling, Artwork & U.S. Advertising & Promotion (GLAAM)
Position Summary
The Regulatory Affairs Manager, Global Labeling Compliance & Operations will support the execution, governance, and continuous improvement of global labeling and regulatory processes across the GLAAM organisation. The role will partner closely with Global Labeling Leads, Regulatory Affairs, Safety, Medical, Quality and Operational Excellence teams to ensure regulatory compliance, data integrity, and efficient management of labeling activities throughout the product lifecycle.
The successful candidate will apply regulatory knowledge and compliance oversight to support global labeling operations, drive process improvements, maintain inspection readiness, and ensure alignment with global regulatory requirements and internal standards.
Key Responsibilities
Regulatory Compliance & Labeling Oversight
- Support regulatory compliance oversight activities across global labeling processes and systems.
- Ensure labeling data, documentation, and records are maintained in accordance with internal procedures and global regulatory requirements.
- Monitor labeling compliance metrics and identify areas of regulatory risk, process gaps, and opportunities for improvement.
- Partner with Global Labeling Leads to support timely execution of labeling deliverables and regulatory commitments.
- Contribute to inspection readiness activities and support internal audits, quality events, CAPAs, and regulatory inspections where required.
- Assist with investigations relating to labeling compliance issues, data discrepancies, and process deviations.
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Global Regulatory Operations
- Maintain oversight of global labeling portfolios and support resource planning activities through analysis of project data and regulatory workload forecasting.
- Review and analyse regulatory system data to ensure accuracy, completeness, and alignment across key regulatory databases and reporting tools.
- Work with Regulatory Affairs SMEs to resolve data quality issues and ensure regulatory records accurately reflect product lifecycle activities.
- Support governance of labeling submissions, approval workflows, and implementation activities across multiple markets.
Regulatory Process Excellence
- Drive continuous improvement initiatives across labeling and regulatory business processes.
- Analyse compliance and operational performance data to identify trends and recommend enhancements to systems, workflows, and procedures.
- Contribute to the development and maintenance of SOPs, work instructions, job aids, training materials, and regulatory guidance documents.
- Act as a project lead or coordinator for cross-functional initiatives focused on operational efficiency, compliance, and process optimization.
Stakeholder Management
- Serve as a regulatory compliance and labeling process subject matter resource for internal stakeholders.
- Collaborate with Global Regulatory Affairs, Labeling, Safety, Clinical, Quality Assurance, Medical Affairs, and Regulatory Operations teams.
- Support training and education activities to promote consistent application of regulatory requirements and labeling standards across the organisation.
- Communicate compliance trends, risks, and improvement opportunities to leadership and key stakeholders.
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Candidate Profile
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related scientific discipline.
- 5+ years of experience within Regulatory Affairs, Regulatory Operations, Labeling, or Regulatory Compliance in a pharmaceutical or biotechnology environment.
- Experience supporting global regulatory activities within a multinational organisation.
- Strong understanding of global labeling requirements and regulatory compliance principles.
- Demonstrated experience working within regulated GxP environments.
Preferred Qualifications
- Advanced degree in Regulatory Affairs, Life Sciences, or related field.
- Experience supporting global labeling strategy and lifecycle label maintenance activities.
- Knowledge of FDA, EMA, MHRA, and ICH regulatory requirements.
- Experience supporting health authority commitments, inspections, audits, and compliance remediation activities.
- Regulatory Affairs Certification (RAC) desirable
An excellent opportunity to join one of the top 5 global pharmaceutical companies on a 12-month basis. A rare opportunity to also work remotely within the UK and join a fast-paced and high-energy team. For more information, please reach out to lucy.kirkaldy@cpl.com
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