SR. REGULATORY AFFAIRS ASSOCIATE
Round Lake, IL
Req ID 51197BR
Business Title
Sr. Regulatory Affairs Associate
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Job Description
Summary:
Under limited supervision responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter's products.
Essential Duties and Responsibilities:
•Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
•Prepare, review, and approve labeling and SOP's
•Participate as an active team member and provide regulatory advice to project teams as required
•Respond to regulatory authorities questions with strict deadlines
•Maintain regulatory files in a format consistent with requirements
•Develop regulatory project plans
•Support regulatory activities relating to specific portfolio of products/projects (product owner)
•Maintain and update existing regulatory authorizations
•Represent or lead Regulatory Affairs in small project teams
•May review promotional material for compliance with local regulations
Job Requirements
Qualifications:
•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 Education/Experience:
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/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.
