Regulatory Manager Position

New

Skills

Clinical Development Compliance Management Document Review Financial Management Project Coordination Regulatory Affairs Regulatory Intelligence Scientific Communication Submission Management Team Leadership

The Regulatory Manager / Senior Regulatory Manager plays a pivotal role in providing regulatory guidance throughout the clinical development life cycle. This position involves compiling, coordinating, and reviewing regulatory submissions, as well as representing Global Regulatory Affairs in project team meetings.

Key Responsibilities
  • Provide regulatory guidance throughout the clinical development life cycle.
  • Compile, coordinate, and review regulatory submissions (CTA/IND, reports).
  • Develop and/or review documents for submission to regulatory authorities and ethics committees.
  • Represent Global Regulatory Affairs at project team meetings.
  • Lead projects for the region or globally and coordinate Regulatory Affairs specialists.
  • Maintain project plans, trackers, and regulatory intelligence tools.
Requirements & Qualifications
  • Bachelor's degree or equivalent in a scientific or healthcare discipline.
  • 5 years regulatory experience for Manager; 7 years for Senior Manager.
  • Computer literacy (MS Office/Office 365).
  • Fluent in English; graduate/postgraduate preferred.
  • Basic understanding of financial management.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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