Regulatory Affairs Associate III

Roles & Responsibilities:

• 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.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 
• Scientific knowledge Written and verbal communication skills. 
• 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.