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Urgent! Regulatory Affairs Associate III Job Opening In Boulder – Now Hiring Katalyst HealthCares & Life Sciences

Regulatory Affairs Associate III



Job description


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 % 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.

  • Requirements:

  • Bachelor s degree or country equivalent in pharmacy or related scientific discipline with - years regulatory experience, preferably within a healthcare environment.


  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.


  • Scientific knowledge Written and verbal communication skills.


  • Systems skills ( 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.



  • Required Skill Profession

    Business Operations Specialists



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      Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide


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