ParexelSenior Regulatory Affairs Associate-Diagnostic Imaging and Interventional Radiology
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
CMC 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.