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
