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Job Title: Regulatory Affairs Associate

Reports to: Regulatory Affairs Director

Purpose: The Regulatory Affairs Associate assists the Regulatory Affairs Director and Quality Department with maintaining controlled documents and creating regulatory submissions in compliance with regulatory standards and guidelines.

Duties and Responsibilities:

(*Denotes essential job functions.)

  • Assists with creating and maintaining regulatory timelines and tracking deliverables to timelines to ensure regulatory submission timelines are met*.
  • Assists with development strategy and preparation for team/project meetings*.
  • Assists with development and/or review of regulatory documents to ensure that all submissions are of high quality.*
  • Assists with review of labeling (including advertising and promotional materials) and analytical and clinical repots for regulatory compliance*
  • Submits electronic data to meet deadlines and regulations*
  • Interfaces with functional areas (Production, QA, QC, Engineering) to identify and obtain information required for regulatory submissions*.
  • Assists with preparing/coordinating/filing/managing regulatory applications (NDAs), annual reports, and information amendments for multiple protocols.*
  • Performs literature searches and extracts information to support regulatory submission.
  • Scans, files and archives documents*
  • Maintains testing standards and other QC documents*
  • Ensures documents meet approved format and template*
  • Tracks training requirements*
  • Analyzes and compiles chemistry reports and data*
  • Maintains knowledge of current global rules, regulations, and guidance documents governing pharmacueticals.*
  • Collaborates in cross-functional teams*
  • Follows all Aurora Pharmaceutical policies, procedures, regulations and the employee handbook.*
  • Follows designated work schedule.*
  • Assumes additional responsibilities as requested.*
  • Accepts and acts upon supervisory directions.*
  • Supports supervisor’s role.*
  • Demonstrates flexibility, i.e. willingly takes on new tasks.*

Knowledge, Skills & Abilities:

  • Excellent knowledge of  Adobe and MS Office (Word, Excel, Powerpoint)*
  • Must have ability to learn new software quickly*
  • Strong technological aptitude*
  • Must be detailed oriented  and highly organized*
  • Must be able to multi task and prioritize*
  • Must have strong verbal, written and interpersonal communication skills.*


  • BA/BS degree in a science field required; Regulatory Science program or RAC highly preferred.
  • Prefer 2 years of experience in Regulatory Affairs in the Pharmaceutical industry.


To apply for this position, please send your resume to