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
Drive regulatory strategy and deliverables regarding company core data sheets (CCDS) and respective Regulatory systems, for therapeutic and combination products. Manage the initial development, approval and ongoing compliance of therapeutic and combination product labeling content throughout the product life cycle. Lead cross-functional teams to manage CCDS/label content, standardize, and enable best practices across all businesses.

What you'll be doing

Lead creation and maintenance of Company Core Data Sheets (CCDS)/Company Core Safety Information (CCSI) activities in support of new and existing marketing authorizations.Drive global implementation of CCDS into country-specific labeling and provide strategic labeling recommendations.Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on market.Formulate and drive global technology, process and solution initiatives to standardize, and enable best practice in labeling and content management.Provide technical and strategic input for regulatory decisions aligned with business strategy.Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups.Provide technical and strategic input for role-based regulatory decisions aligned with business needs.Monitor, evaluate, and interpret applicable regulatory requirements, assure compliance with Baxter and external standards.Assess impact of new regulations and provide feedback.Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.Act as a contact for meetings with regulatory authorities including planning and leadership.Maintain appropriate communication within the RA function and with other functions.Plan and manage complex projects and prioritize workload.Initiate, manage and maintain role-based operational activities.Represent Baxter interests in industry and working groups.Set team, group, or service objectives to assure they align with the regulatory strategy.Provide direct supervision of individuals including mentoring, performance management and staffing decisions.

What you'll bring

Bachelor's degree or country equivalent in a scientific discipline. Masters and/or PhD will be an advantage.Minimum of 7-year experience in RA, including managing people or projects and at least 2 years of CCDS experience.Ability to work effectively in multinational/multicultural environmentManagement skillsTechnical and management skillsExpert Regulatory knowledgeSound basis of Scientific (Training/Communications) knowledgeAbility to oversee multiple projects in a matrix team environmentExcellent oral and written communication and presentation skillsDemonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting prioritiesAbility to lead, coach, and motivate othersAbility to accomplish results through others
 

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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

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.