Sr Manager, Regulatory Affairs (Remote)

This is where you save and sustain livesAt 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 BaxterDrive 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 doingLead 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.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 bringBachelor'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 environment.Management skills.Technical and management skills.Expert Regulatory knowledge.Sound basis of Scientific (Training/Communications) knowledge.Ability to oversee multiple projects in a matrix team environment.Excellent oral and written communication and presentation skills.Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.Ability to lead, coach, and motivate others.Ability to accomplish results through others.

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