Manager, Global Regulatory Affairs Ad PromReq # JR - 023883 Location Deerfield, Illinois, United States Job Category Regulatory Affairs Date posted 06/30/2020
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The Manager of Regulatory Affairs-Advertising/Promotion reports to the Associate Director Global Regulatory Affairs-Advertising & Promotion, and is responsible for the review of Advertising and Promotional (Ad Prom) material and accountable for all operational aspects of regulatory submissions providing planning and technical support for Baxter’s products for one or more business units/countries.
Essential Duties and Responsibilities
- Review and approve advertising and promotional material
- Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
- Plan and manage complex projects and prioritize workload
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
- Maintain appropriate communication within the RA function, SBU marketing, and other functions primarily at the project team level
- Communicate proactively and report to regulatory authorities
- Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
- Assess impact of new regulations and provide feedback.
- Set team, group, or service objectives to assure they align with the Regulatory strategy
- Provide technical and strategic input for regulatory decisions
- May manage budget at country level
- May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
- ~5 years of direct experience in Regulatory Affairs Advertising & Promotion, including managing people or projects and reviewing material. Higher degree/PhD will be an advantage.
- Expert Regulatory knowledge in the Ad Prom space and other Regulatory functions
- Scientific knowledge
- Strong ability to work with cross-functional teams
- Ability to oversee multiple projects in a matrix team environment.
- Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
- Excellent oral and written communication and presentation skills.
- Ability to accomplish results through others
- Ability to lead, coach, and motivate others
- Bachelor’s degree or country equivalent in related scientific discipline
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.
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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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.