Senior Director Regulatory Affairs (AdProm)
Deerfield, IL
Req ID 50458BR
Business Title
Senior Director, Regulatory Affairs (AdProm)
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 advertising and promotion function. Applies strategic direction, critical review skills and creative solutions to diverse promotional scenarios. Significant expertise with application and interpretation of regulations and guidances.
•Communicates/negotiates directly with the FDA on advertising and promotional labeling-related activities.
•Assumes a leadership role in regulatory compliance efforts. 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.
•Ensures, through regular communication, that regulatory activities support business and marketing needs. Liaises with a matrixed review team including senior-level 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 measures, evolving regulatory requirements and enforcement trends
Job Requirements
•Experience working directly with OPDP/DDMAC or APLB is essential.
•Expert working knowledge of regulations and their implementation and specific experience in the area of advertising and promotion and the ability to support of multiple commercial products is required. Works on projects of diverse scope,
•Demonstrated ability to identify emerging issues and initiate actions to recommend solutions, including in areas of ambiguity
•Expert regulatory and pharmaceutical industry knowledge and proficiency with representing/interpreting the strategic business objectives of the company is critical.
•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.
•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 12 years experience in RA, including at least 7 years experience managing people.
•Higher degree/PhD will be an advantage.
•International experience/exposure 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.
