Director Regulatory Affairs (Ad\Promo)
Deerfield, IL
Req ID 50020BR
Business Title
Director, Regulatory Affairs (Ad/Promo)
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
•Guides, directs and coordinates the strategic planning of the Regulatory Affairs BioScience advertising and promotion function. Applies critical review skills and creative solutions to diverse promotional scenarios
•Communicates directly with the FDA on advertising and promotional labeling-related activities.
•Ensures that advertising and promotional labeling materials meet FDA and Baxter standards.
•Directs the activities of Regulatory Affairs staff relative to milestones and timelines. Provides appropriate staffing for the Regulatory Affairs function, in accordance with projected product/project needs. Trains and develops staff as appropriate.
•Ensures, through regular communication, that regulatory activities support business and marketing needs. Liaises with a matrixed review team including Marketing, Legal, Medical and Engineering disciplines as relevant
•Surveys, evaluates and interprets regulatory requirements relative to advertising and promotional labeling and disseminates information and impact of changes in regulatory policies to appropriate management.
•Educates departments regarding required regulatory compliance.
Job Requirements
•Experience working directly with OPDP/ DDMAC or APLB is a must.
•Expert knowledge of regulations and their interpretation, implementation and specific experience in the area of advertising and promotion and the ability to support of multiple commercial products are required.
•Excellent written and verbal communication skills and computer literacy are required.
•Demonstrated leadership skills and demonstrated ability to interact with senior management.
•Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality are essential.
•Risk management and problem solving skills
•Ability to lead, mentor, and develop others for future growth and development
•Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, Higher degree/PhD will be an advantage. International experience/exposure preferred.
•Applies and understands business strategy.
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.
