AdresExternal Job Description
The IQVIA Connected Regulatory Intelligence (CRI) is a groundbreaking innovative solution that simplifies, integrates, and automates end-to-end regulatory processes that are essential for industry clients in meeting their global quality, regulatory and safety compliance obligations. CRI provides the pharmaceutical and medical device industries easy access to original and translated regulatory documents, summarized Regulatory Intelligence and comparative tables with up-to-date key regulatory requirements worldwide. As we look to develop our regulatory offering further, this role is to be part of the team designing for the future of Regulatory Intelligence.
Principal Accountabilities
Authoring high quality regulatory content to aid in regulatory affairs submissions and facilitate the application of regulatory strategies
Real time monitoring and analysis of changes in the regulatory landscape for an assigned set of countries
Prepares regulatory information in area of content as per project schedules
Depending on experience, gives guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
Liaising with internal and external stakeholders to provide expert support
Essential Experience
Qualifications in life sciences or related discipline
Experience in regulatory submissions for pharmaceutical products, such as new product registrations, variations, MAAs, MATs, etc.
Possesses at least 2-3 years of relevant regulatory affairs experience and/or technical expertise in industry or in a consultancy firm preparing application dossiers and gathering regulatory information
Technical Skills
Experience & knowledge of various databases (public/proprietary)
Proficient in MS Office – Excel, Word, PowerPoint
Personal Skills
Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
Demonstrates self-motivation and enthusiasm; desire to learn new concepts and skills
Excellent communication (verbal/written) skills
Strong attention to detail
Strong interpersonal skills and ability to interact at all levels within IQVIA
Flexibility (should be ready to take additional responsibility as and when required)
Ability to solve problems quickly and logically
Team player and ability to collaborate at all levels but also able to work under own initiative
Adept time and project management
The opportunity:
You will be working on a groundbreaking innovative solution and directly impact patient health through transforming client operations that bring safe and effective medical product to global markets in optimized timelines.
We are a diverse, global team that shares a passion for collaboration and solving problems using best functional expertise and most advanced technologies to transform how regulatory teams do their daily jobs. Together, we will make a difference.
Unleash Your Potential.
It takes brave minds to bring powerful ideas to reality.
Join IQVIA and see where your skills can take you.
#LI-REMOTE
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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