Associate Regulatory Affairs Director, Labelling Coordinator

Overview

In this role you direct and oversee complex labeling and regulatory projects, ensuring timely, compliant deliverables and adherence to SOPs. You provide strategic regulatory and technical guidance across projects, supporting global initiatives and mentoring junior colleagues. You may lead meetings with regulatory bodies and present or defend proposals, shaping patient-focused regulatory outcomes. You will work closely with cross-functional teams to manage risks and drive continuous improvement in labeling programs.

Responsibilities

• Direct large stand-alone regulatory programs with multiple deliverables
• Conduct risk analysis and contingency planning
• Provide strategic regulatory/technical consultancy to internal and external stakeholders
• Lead or participate in meetings with Regulatory Agencies
• Draft or review regulatory proposals and justify costs and timelines
• Mentor junior colleagues and advise on regulatory document types
• Plan and deliver workshops or presentations on Labeling/Regulatory topics
• Review/approve regulatory and cross-functional SOPs
• Support global regulatory initiatives as a Subject Matter Expert
• Perform additional tasks as delegated by regulatory management

Key requirements

• Bachelor in Life Science or related discipline
• 12+ years relevant experience with at least 8 years in labeling regulatory experience
• Extensive experience with EU labeling submissions
• Advanced negotiating and influencing skills
• Calm, assertive, diplomatic in challenging interactions with customers
• Strong MS Office and software skills
• Ability to exercise independent judgement and take calculated risks
• Applicable certifications/licences as required by regulatory bodies (where applicable)

• Negotiation and influencing
• Calm under pressure and diplomacy
• Effective communication across levels
• EU labeling updates submissions
• Regulatory affairs knowledge and processes
• MS Office applications

…