Senior Labeling & Regulatory Strategy Director

Iqvia; Reading; On-site; GBP 120,000 - 190,000; Full time

Job summary

IQVIA is seeking an Associate Regulatory Affairs Director, Labelling Coordinator to lead complex labeling and regulatory programs from Reading, Berkshire, United Kingdom. You will oversee deliverables, ensure SOP-compliant work, and drive strategic consultancy for regulatory matters across regions.

The role demands extensive EU labeling update experience, senior negotiation skills, and the ability to mentor colleagues while engaging with regulatory agencies and clients.

Qualifications

• Bachelor's Degree in Life Science or related discipline.
• Master's Degree in Life Science or related discipline.
• At least 12 years relevant experience including 8 years labeling regulatory experience or combination of education, training and experience.
• Extensive experience in EU labeling updates submissions.
• Advanced negotiating and influencing skills and the ability to identify and resolve issues.

Responsibilities

• Direct, oversee and manage labeling and regulatory projects, ensuring quality deliverables on time and within budget.
• Act as Project Manager for large programs with regulatory/technical deliverables across regions.
• Provide strategic regulatory/technical consultancy to projects, internally and externally.
• May manage meetings with Regulatory Agencies.
• Write/review complete regulatory proposals and defend costs/timelines to clients.
• Mentor junior colleagues and advise on regulatory document types.
• Plan/deliver workshops or presentations on Labeling/Regulatory Affairs topics.
• Review/approve regulatory SOPs or cross-functional SOPs.
• Support global regulatory or technical initiatives as SME.

Skills

Regulatory strategy

Project management

Negotiation

Communication

Education

Bachelor's degree in Life Science

Master's degree in Life Science

Tools

MS Office

Job description

IQVIA is seeking an Associate Regulatory Affairs Director, Labelling Coordinator to lead complex labeling and regulatory programs from Reading, Berkshire, United Kingdom. You will oversee deliverables, ensure SOP-compliant work, and drive strategic consultancy for regulatory matters across regions.

The role demands extensive EU labeling update experience, senior negotiation skills, and the ability to mentor colleagues while engaging with regulatory agencies and clients.