Associate Regulatory Affairs Director, Labelling Coordinator

IQVIA Holdings Inc.; Reading; On-site; GBP 120,000 - 150,000; Full time

Job summary

IQVIA is seeking an experienced regulatory labeling professional to lead complex labeling/regulatory projects with focus on EU submissions and SOP compliance.

You will deliver strategic regulatory consultancy, mentor junior staff, and engage with Regulatory Agencies as needed to ensure high-quality, timely results across regions.

Qualifications

• Bachelor's degree in Life Science or related discipline.
• Master's degree in Life Science or related discipline.
• At least 12 years of 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.
• Strong software and computer skills, including MS Office applications.

Responsibilities

• Direct, oversee and manage complex labeling and regulatory projects.
• May act as a Project Manager for a large stand-alone program with several regulatory or technical deliverables.
• Provide strategic regulatory/technical consultancy on a variety of projects.
• May manage meetings with Regulatory Agencies.
• May write and/or review complete regulatory proposals and defend costs and timelines to clients.
• Mentor junior colleagues and advise on regulatory document types.
• Plan and deliver workshops or presentations on labeling/regulatory topics.
• Reviewer/Approver for regulatory SOPs and cross-functional SOPs.
• Support global regulatory or technical initiatives or act as Subject Matter Expert.

Skills

Project management

Regulatory affairs

Negotiation

MS Office

Education

Bachelor's degree in Life Science

Master's degree in Life Science

Tools

MS Office

Job description

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.,

• 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
  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 a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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.