Senior Regulatory Associate

Designation: Regulatory Associate

Location: USA

Qualification: Bachelor’s Degree


Sr. Regulatory Affairs Specialist needed to perform the following job duties:

  • Supporting China TRD Remediation as business unit lead working with and communicating with China RA team and collaborating with local cross function team.
  • Supporting Global requests from RA affiliates to support re-registrations.
  • Updating Technical Files and appropriate filing.
  • Compile 510(K) and Post Market Approval (PMA) submission  supplements and annual reports to maintain commercial approvals in the USA.
  • Compile original Technical Files and Design Dossier submissions seeking commercial approval of unapproved assigned product lines in the European Union.
  • Provide ongoing support to various cross-functional teams in their requests from regulatory affairs on manufacturing changes and the regulatory submission implications.

Bachelor’s degree required in Chemistry or Regulatory Affairs or Biology or PharmD.

Apply for this job