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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate-Diagnostic Imaging and Interventional Radiology
Job ID R0000038452 , IndiaCMC authoring, pharmaceutical products- Diagnostic Imaging and Interventional Radiology
- Knowledge of contrast media, injection solutions in medical imaging (MRI/CT)
- Authoring of the CMC part of dossiers including coordination and review with stakeholders for Worldwide submissions such as EEA, US and other regions
- Experience in managing new registrations, life cycle maintenance, and renewals for medical imaging products
- Delivery of regulatory submissions from a global and regional perspective, regulatory change control assessments, preparing responses to health authority questions
- Good understanding of the regulatory framework, including regional trends, for various types of applications and procedures for imaging pharmaceuticals for worldwide filings, specifically linked to CMC aspects.
- Expertise with regulatory management system and document management systems.
- Effective communication and collaboration skills, and the ability to work independently.
5 to 8 Years of relevant experience
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