Regulatory Affairs (Sr.) Associate

 

Regulatory Leadership within a growing pharmaceutical company has tasked Junto HLS with recruiting a Regulatory Affairs (Sr.) Associate.

Select Accountabilities:

  • Creation and support of electronic management of health authority submissions
  • Management of the regulatory affairs filing system
  • Maintaining and helping to further develop/define effective strategies for filing of regulatory documentation
  • Reviewing  documents for completeness and compliance with regulatory requirements
  • Providing formatting support for documents to ensure consistency within and between documents and with document templates
  • Supporting   production, assembly and publishing of submission documents
  • Coordinating electronic submission issues to ensure compliance and document management standards
  • Serving as a liaison to e-submission vendors
  • Keeping abreast of regulatory procedures and changes
  • Providing administrative and related project support
  • Execution of research and data analysis tasks, including problem analysis, compilation and analysis of data and preparation of reports and presentations
  • Acting as a key representative in related internal audits and third-party inspections
  • Coordination of activities between departments and outside parties
  • Contacting company employees at all organizational levels to gather information and prepare reports

Location(s):

  • Greater Boston, MA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.