Senior Regulatory Affairs – Labelling Expert (Hybrid UK)

PE Global (UK); Basingstoke; On-site; GBP 30,000 - 40,000; Full time

Job summary

PE Global is seeking a Senior Regulatory Associate to manage regulatory affairs for the UK & Ireland marketing affiliate, plus the Maltese affiliate. The role focuses on regulatory plans, new product registrations, line extensions and post-approval activities with strong labeling experience.

Based in Basingstoke with hybrid working, you will ensure compliance with local regulatory and quality requirements, support launches, maintain licenses, and interact with regulatory bodies across multiple

Qualifications

• Bachelor's degree in a relevant scientific subject.
• At least one year of industry experience within Regulatory Affairs.
• Significant pharmaceutical labeling experience – essential.
• Experience with external regulatory agencies.
• Knowledge of quality systems.

Responsibilities

• Execute the Regulatory Plan in alignment with affiliate business objectives and local regulatory requirements.
• Prepare and support regulatory applications for new marketing authorisations, line extensions and other regulatory submissions.
• Support timely responses to requests from regulatory authorities and internal support functions.
• Maintain existing marketing authorisations, including renewals, variations and periodic reporting activities.
• Track regulatory changes, assess their impact and communicate requirements across relevant internal teams.
• Support product launch teams by identifying regulatory considerations and helping deliver launch plans.
• Represent Regulatory Affairs within cross-functional brand teams and New Product Planning discussions.
• Maintain regulatory tools, trackers and metrics in line with compliance requirements.
• Facilitate interactions with regulatory bodies and support relationships with relevant regulatory agencies and trade associations.

Skills

Regulatory affairs

Pharma labeling

Quality systems

Stakeholder communication

Regulatory compliance

Education

Bachelor's degree or equivalent in a relevant scientific subject

Job description

PE Global is seeking a Senior Regulatory Associate to manage regulatory affairs for the UK & Ireland marketing affiliate, plus the Maltese affiliate. The role focuses on regulatory plans, new product registrations, line extensions and post-approval activities with strong labeling experience.

Based in Basingstoke with hybrid working, you will ensure compliance with local regulatory and quality requirements, support launches, maintain licenses, and interact with regulatory bodies across multiple