regulatory strategist - non clinical - Denver - beBeeNonClinical

    beBeeNonClinical
    beBeeNonClinical Denver

    4 days ago

    Job title: Senior Nonclinical Regulatory Strategy Lead

    Description

    Key Responsibilities:



    1. This role will be responsible for driving strategic planning, authorship, and execution of nonclinical components across multiple projects simultaneously.



      • Developing clinical trial applications and amendments that meet strict regulatory requirements.

      • AUTHORING NONCLINICAL SECTIONS FOR REGISTRATION DOSSIERS APPLICABLE IN THE US AND EU REGION WITH COMPLETE ACCURACY AND TIMELINESS.

      • Preparation and submission of Annual Reports, INDs & NDA with high accuracy.
        The final reports shall have minimum number of errors which could reflect poorly on our company image when scrutinized by external auditors at various levels- federal state local government etc...
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