Regulatory Affairs Specialist

Reports to: Regulatory Affairs Director

Purpose: The Regulatory Affairs Specialist works with the Regulatory Affairs Director and Quality Department with maintaining controlled documents and creating regulatory submissions in compliance with regulatory standards and guidelines. The Regulatory Affairs Specialist participates in communication with regulatory agencies.

Duties and Responsibilities:

(*Denotes essential job functions.)

· Creates and maintains regulatory timelines and tracks deliverables to timelines to ensure regulatory submission timelines are met*.

· Assists with development strategy and preparation for team/project meetings*.

· Develops and/or reviews regulatory documents to ensure that all submissions are of high quality*

· Updates drug listings, submits safety reports*

· 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*.

· Prepares/coordinates/files/manages regulatory applications (supplements), annual reports, and information amendments for multiple protocols, using eCTD format and/or eSubmitter tool*

· Performs literature searches and extracts information to support regulatory submission.

· Scans, files and archives documents*

· Ensures documents meet approved format and template*

· 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.*

Education:

· BA/BS degree in a science field required; Regulatory Science program or RAC highly preferred.

· Require 5 years of experience in Regulatory Affairs in the Pharmaceutical industry.