Regulatory Affairs Associate III

Pay Range : $ 40/hr to $ 63/Hr (Depending on Experience & Skills)

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.