Associate Regulatory Affairs Director, Labelling Coordinator

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

Job Overview

Direct, oversee and manage complex labeling and regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with standard operating procedures, policies and practices.

Essential Functions

• May act as a Project Manager for a large stand-alone program, involving several regulatory or technical deliverables and/or region, and/or operation; Undertakes risk analysis, management and contingency plans, as appropriate;
• Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate;
• May manage meetings with Regulatory Agencies;
• May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients;
• Provides mentorship to junior colleagues and advise others on many regulatory document types;
• May plan and deliver workshops or presentations on Labeling / Regulatory Affairs topics for conferences or publications;
• May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations;
• May support global regulatory or technical initiatives or act as a Subject Matter Expert.
• Performs other tasks or assignments, as delegated by Regulatory management;

Qualifications

• Bachelor's Degree Degree in LiveScience or related discipline Req Or
• Master's Degree 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, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
• Strong software and computer skills, including MS Office applications
• Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
• Ability to exercise independent judgement taking calculated risks when making decisions
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Associate Regulatory Affairs Director, Labelling Coordinator • Reading, Berkshire, United Kingdom