Regulatory Affairs Specialist

Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

Requirements

Experience in dossier development of Module 3 IND/IMPD or MAA/BLA
Able to work in a Documentum System
Skilled in Word
Hands on dossier development experience
RA CMC guideline knowledge
Good communication Skills
at least 5 years of work experience in a similar role