Senior Regulatory Affairs Associate-Diagnostic Imaging and Interventional Radiology
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were 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 managingnew 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
Required Experience:
Senior IC
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
