REGULATORY AFFAIRS SPECIALIST
Round Lake, IL
Req ID 51430BR
Business Title
Regulatory Affairs Specialist
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
•Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
•Prepare, review, and approve labeling and SOP's. Assist lower level team members on complex issues.
•Provide regulatory advice to project teams.
•Provide guidance and coaching for areas of responsibility to lower level team members.
•Respond to regulatory authorities questions with strict deadlines
•Maintain regulatory files in a format consistent with requirements• Develop and initiate complex regulatory project plans
•Manage regulatory activities relating to specific portfolio of products/projects (product owner)
•Maintain and update existing regulatory authorizations
•Lead or represent Regulatory Affairs in project teams
•May review promotional material for compliance with local regulations
Job Requirements
•Exercise independent judgment
•Ability to evaluate and identify product changes and assess them to global regulatory requirements.
•Written and Verbal communication skills
•Knowledge of regulations - US and OUS
•Strong 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 in science or engineering or a minimum of 5 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
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.
