MANAGER REGULATORY AFFAIRS
Round Lake, IL
Req ID 48979BR
Business Title
Manager, Regulatory Affairs
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
The Manager of Global Regulatory Affairs (GRA) will be responsible for defining regulatory strategies and managing submission activities in support of new and existing marketing authorizations for Fluid Systems IV Therapy Products.
•Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
•Represent or lead the GRA function on assigned cross-functional project teams
•Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
•Establish appropriate communication within GRA, regional/country RA and other functions primarily at project level
•Perform gap analysis and propose solutions
•Develop and document sound regulatory decisions and justifications
•Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
•May provide direct supervision of individuals
•May review promotional material or SOP's for compliance with local and global regulations
Job Requirements
•Sound basis of drug regulatory knowledge
•Scientific knowledge
•Ability to manage complex projects and timelines in a matrix team environment
•Strong oral and written communication and presentation skills
•Demonstrated interpersonal skills including strong negotiation skills
•Ability to independently identify compliance risks and escalate when necessary
•Ability to lead and coach others
•Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects.
•Higher degree/PhD will be an advantage. This posiiton will initially be in our McGaw Prak location, but will ultimately be located on our Round Lake, IL campus.
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.
