IQVIA
Associate Regulatory Affairs Director, Labelling Coordinator
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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;
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Qualifications
- Bachelor's Degree Degree in Life Science 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
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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.
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