Regulatory Affairs Associate
McGaw Park, IL
Req ID 49890BR
Business Title
Regulatory Affairs Associate
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
McGaw Park - Gr, IL
Shift_
1st
Job Description
•Coordinate activities between Global Regulatory Leads and CMC
•Support regulatory activities relating to specific portfolio of products/projects (Drugs and/or devices)
•Compile regulatory documents according to regulatory requirements in support of global submissions
•Provide regulatory files in a format consistent with country requirements
•Assist with responding to regulatory authorities questions with strict deadlines
•Participate as an active team member and provide regulatory advice to project teams as required
•Represent or lead Regulatory Affairs in small project teams
Job Requirements
•Scientific knowledge
•Written and Verbal communication skills
•Knowledge of regulations
•Negotiation skills
•Technical system skills (e.g. word processing, spreadsheets, databases, online research)
•Manage multiple projects and deadlines
•Ability to identify compliance risks and escalate when necessary
•Bachelor's degree or country equivalent in pharmacy or related scientific discipline with a minimum of 0-2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
•Higher degree/PhD will be an advantage.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.