Kaleo Software

Compliance

• Develops and implements regulatory strategies to facilitate the progress of programs in all phases of development.
• Prepare annual reports, supplements, amendments, and change notifications to regulatory agencies and ensure periodic reports are submitted to regulatory dossiers.
• Participate with team members in drafting and submitting dossiers in different regions around the world, including Chemistry, Manufacturing, and Controls (CMC); nonclinical; human factors; clinical; and pharmacovigilance activities.
• Assist in drafting and reviewing product labeling.
• Review clinical and non-clinical study protocols and other documentation, and assess clinical study related changes to determine regulatory impact.
• Review human factors study protocols and other human factors documentation.
• Support regulatory audits, as required.
• Assist in developing and maintaining Regulatory Affairs department procedures.

Senior Specialist, Regulatory Affairs