Director Regulatory Affairs, Global Advertising and Promotion (medical device and pharmaceutical)
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Your Role at Baxter:
As the Director Regulatory Affairs, Global Advertising and Promotion you will be responsible for developing and delivering strategic planning and functional responsibilities of the Regulatory Advertising and Promotion (AdProm) Team aligned to GRA (Global Regulatory Affairs) and Segment/Division/Business needs. You will lead the coordination within Global Strategy and Delivery (GSD) team for supporting regulatory requirements, submissions and compliance related to advertising/promotional materials and Company Core Data Sheet (CCDS - labeling impacting activities).
What You’ll Be Doing:
• Provide vision and strategy for an AdProm team to implement and execute across multiple areas of responsibility – process and system, leadership and guidance to business partners, while assuring compliance with all applicable regulations.
• Develop and deliver upon forward looking strategies with business partners to effectively navigate complexity and ambiguity, for generating standardized consistent processes that meet both business goals and compliance requirements. Ensures labeling impacting strategies are in-line with business needs.
• Lead and manage a team of direct reports and may manage other people leaders. Hire, develop, and retain diverse top talent in the team. Set clear and elevating goals for the team and individual direct reports. Coache direct reports on their performance, development, and career interests.
• Oversight and accountability for labeling impacting activities (CCDS) managed by external vendor(s) for assigned product lines, ensuring seamless coordination, timely delivery, and adherence to quality standards.
• Champion and influence partners in the adoption of a consistent and standardized process to allow for greater collaboration, enabling projects to progress with more differentiated ideas & solutions that have a positive impact upon the organization.
• Hold team leads accountable to execute overall program deliverables and timelines to agreed schedule and technical specification. Manage workload within assigned team and work with other managers/team leads within functional area to address resource challenges.
• Initiate and maintain appropriate communications within the RA function and represent Regulatory Affairs with business partners. Interface and align with other regulatory affairs sub-functions to provide seamless support to the project teams.
• Ensure effective communication and teamwork exists to facilitate smooth operation of regulatory systems so that operating teams remain in compliance with all applicable regulations.
• Represent Baxter externally in industry working groups related to role and provide influence to drive policy decisions and future regulations.
• Develop and maintain current regulatory knowledge in the areas of advertising and promotion and CCDS and advises management of significant developments. Ensures that the regulatory environment is continually monitored for new regulations, guidance, enforcement priorities and trends.
• Drive appropriate metrics and key performance indicators for the responsible work areas and use metrics to develop and enhance both capability & capacity.
• Support budgeting and forecasting for function and Regulatory Affairs department.
• Prioritize and balance Line management & Project facing responsibilities as per the requirement. Serve as point of escalation for team members and business partners.
• Participate in quality and/or continuous process improvement activities related to area of responsibility or as requested. Recognize matters that affect corporate or agency policies and escalates issues with high business impact or risk.
Your Team:
The Director Regulatory Affairs, Global Advertising and Promotion reports to the Senior Director, Regulatory Affairs - Global Strategy & Delivery. The Director leads a team of 12 who are geographically dispersed (US, Canada and UK). The team works collaboratively with Marketing, Regulatory Affairs, Medical Affairs and Legal.
Your Location:
The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Alternatively, the role can work at one of our facilities in Batesville, IN, Raleigh, NC, St. Paul, MN, beautiful upstate New York in a bedroom community outside of Syracuse, Skaneateles Falls or Mississauga, Ontario, Canada. Relocation assistance to the greater Chicago area may be provided. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
What You’ll Bring:
• Bachelor’s degree is required; Biotechnology, Pharmacy, or other Life Sciences related discipline is ideal.
• Minimum of 10 years of experience in Regulatory Affairs for medical device and pharmaceutical products; and a minimum 7 years AdProm experience.
• At least 5 years experience managing people and programs.
• Experience with mergers and acquisitions and related integrations preferred.
• Experience using Veeva PromoMats preferred.
• Diversified experience with progressive responsibilities in Regulatory Affairs, Pharmacovigilance, Intellectual property rights, R&D (Research & Development), Quality Control and related functions of the Baxter Businesses spanning diverse business domains (Medical devices, drugs, and biotherapeutics).
• Demonstrated effectiveness in strategic planning and operational aspects of a global healthcare business.
• Experience in labeling content management and company core data sheets preferred.
• International experience/exposure preferred.
• Demonstrated ability to influence people, policy, and opinion within the organization, as well as through external engagement.
• Demonstrated people development (including people manager) and leadership experience.
• Demonstrated proficiency at conveying complex regulatory information to the business in a clear, focused, and concise manner.
• Knowledge and expertise to manage and lead strategic regulatory programs.
• Proven leadership, technical, communication, and teamwork skills to work in a collaborative environment.
• Ability to think and act strategically while finding balance in managing regulatory risk.
• Demonstrated ability to think strategically and operate in a fast-paced, quick-turnaround environment, requiring hands-on involvement with peers, management, business partners and staff.
• Ability to build and maintain effective relationships with both internal and external business partners to facilitate effective communication and integration of business needs.
• Ability to lead, mentor, and develop others for future growth and development.
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We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $160,000 - $220,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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 globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
