EXAMPLE SCENARIO

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

TYPICAL TASKS ^SRC

• Coordinate efforts associated with the preparation of regulatory documents or submissions
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements or clarification and follow-up of submissions under review
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies
• Coordinate, prepare or review regulatory submissions for domestic or international projects
• Prepare or maintain technical files as necessary to obtain and sustain product approval

EXAMPLE JOB TITLES ^SRC

Drug Regulatory Affairs Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist)