Sr Regulatory Affairs Associate (Labeling)
McGaw Park, IL
Req ID 49430BR
Business Title
Sr Regulatory Affairs Associate (Labeling)
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
McGaw Park - Gr, IL
Shift_
1st
Job Description
The primary responsibility of the Sr. RA Associate will be to create and maintain Company Core Data Sheets (CCDS) for their assigned therapeutic area. Other duties include:
•Assist in life cycle managment of labeling for USPI, EU labeling and regional specific labeling as needed.
•Participate as an active team member and provide regulatory advice to project teams as required for labeling.
•Respond to regulatory authority's questions regarding labeling for assigned products.
•Maintain regulatory files in a format consistent with requirements.
•Monitor CCDS implementation into labeling via label tracking tool and generate respective reports for assigned product line.
•Support regulatory activities relating to specific portfolio of products/projects (product owner).
Job Requirements
Key requirements for this position include:
•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 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
•Higher degree (R.N. or PharmD) is highly preferred.
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.
