To apply for this position, please send your resume to Hrdept@aurorapharmaceutical.com.
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.*
Education:
- 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 Hrdept@aurorapharmaceutical.com.
