Documentation Assistant

Senior 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.

5 to 8 Years of relevant experience

Experience Level

Senior Level