Description:
Can be fully remote or hybrid
Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Track of status and progress of regulatory documentation Review, edit and proofread regulatory documentation Assist in preparation and review of labeling, SOP s, and other departmental documents Compile under supervision regulatory documents for submission Participate as an active team member of project teams as required, Compile and prepare responses to regulatory authorities questions Maintain regulatory files in a format consistent with requirements Maintain awareness of regulatory requirements May be responsible for a specific product portfolio in the region To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Scientific knowledge Written and verbal communication skills Knowledge of regulations Technical systems skills (e.g. word processing, spreadsheets, databases, online research) Proofreading and editing skills Ability to contribute to multiple projects from a regulatory affairs perspective Ability to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily. Bachelor s degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment.
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Additional Details
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