Regulatory Affairs Specialist

2 months ago


Portage, United States GForce Life Sciences Full time

Job Title: Regulatory Submissions Coordinator

Job Description:

As a Regulatory Submissions Coordinator, you will be responsible for coordinating and preparing document packages for regulatory submissions across all organizational areas. Your role will involve collecting all necessary materials for submissions, license renewals, and annual registrations. Staying updated on regulatory procedures and changes will be crucial to your success.

Key Responsibilities:

  • Coordinate and prepare comprehensive document packages for regulatory submissions.
  • Gather and organize materials required for submissions, license renewals, and annual registrations.
  • Stay informed about regulatory procedures and industry changes.
  • May interact with regulatory agencies to facilitate submission processes.
  • Solve complex problems requiring data analysis and evaluation of specific factors.
  • Exercise independent judgment to determine appropriate solutions within broad parameters.
  • Establish methods and procedures for new projects and provide guidance to junior staff as needed.

Qualifications:

  • Typically requires a university degree or extensive practical experience in a related field.
  • Understanding and application of procedures and concepts relevant to the discipline.
  • Ability to make judgments based on practice and previous experience.
  • Must demonstrate the capability to work independently with minimal supervision and apply professional expertise.



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