Baxter Assoc Director, Global Labeling and Advertising and Promotion, Regulatory Affairs in Round Lake, Illinois


  • Independently lead global regulatory labeling strategy development, planning, and implementation for multiple complex programs and platforms for new product development across different business units. Understand and incorporate key labeling requirements and best practices into global labeling strategies and global regulatory planning documents

  • Act as labeling and promotion liaison to core project teams and to other parts of the regulatory organization

  • Develop and obtain approval of the target product profile (TPP) and/or associated company core position on safety and efficacy for a compound (CCDS/CCSI)

  • Utilize technical labeling and promotion regulatory skills in tandem with key SMEs/stakeholders input to collaborate on strategies and develop content that provides solutions to safety or competitive program issues with impact for Baxter

  • Responsible for executing innovative labeling and promotional strategies according to plan with successful outcomes for relevant projects. Evaluate clinical, technical, and scientific information in support of product/labeling claims

  • Responsible for identifying appropriate labeling and promotion standards and content requirements that comply with regulations

  • Responsible for providing input into development plans or developing plans related to safety, efficacy and compliance to ensure successful regional registrations (from a labeling and promotion perspective)

  • Interface and align with other regulatory affairs sub-functions to provide seamless labeling and promotion support to the project team

  • Responsible for negotiating and risk-based decision making with regulators and stakeholders on complex and high-risk projects

  • Participate in identification of risk areas and develop alternative courses of action and propose solutions; including anticipation of regulators responses through scenario planning and development of contingency plans

  • Represent Baxter externally in industry working groups related to labeling and promotion and provide input into policy decisions and future regulations

  • Participate in development and maintenance activities for systems and procedures for pipeline projects

  • Adapts regulatory strategy and plans based on changes to regulatory or competitive environment

  • Monitor the competitive landscape for the product to provide the most competitively advantageous position for Baxter’s products

  • Participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc)

  • Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs across business units and other functions

  • Lead, mentor and coach members within and outside of the department


  • Expert scientific knowledge and ability to apply knowledge in regulatory positioning and planning

  • Sound basis of regulatory knowledge, industry norms, and experience with labeling and promotional development

  • Demonstrated ability to manage complex projects and timelines independently in a matrixed environment including strong project management and organizational skills

  • Strong analytical, project planning, risk identification, and problem solving skills

  • Excellent written and verbal communication, presentation, and facilitation skills

  • Excellent interpersonal and negotiation skills (including regulatory authorities) are required

  • Risk identification and problem solving skills

  • Demonstrated ability to lead, mentor, and develop others for future growth and development

  • Ability to provide strategic and operational guidance across all levels of the company and external vendors

    Education and/or Experience:

  • Minimum 8 years experience in a regulatory function, including at least 5 years of labeling and/or ad prom experience

  • Bachelor’s degree or country equivalent, in life sciences prefeed

  • Master’s degree or above will be an advantage

  • International experience/exposure preferred

  • Device labeling (including advertising and promotion) experience will be an advantage

  • Familiarity with clinical trial protocol development to deliver outcomes favorable to support labeling and promotional claims experience preferred

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.

Job: *Regulatory Affairs

Organization: *Baxter Research & Development - Global Regulatory Affairs

Title: Assoc Director, Global Labeling and Advertising and Promotion, Regulatory Affairs

Location: Illinois-Round Lake

Requisition ID: 180005OK

Other Locations: United States of America-Illinois-Deerfield