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.

Summary

This role is responsible for providing regulatory support for on-market products.  Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.

Essential Duties and Responsibilities

Review and provide global regulatory impact assessments for changesAuthor and manage global submission deliverables for product variation submissionsResponsible for working with other parts of the regulatory organization to achieve desired resultsDevelop and execute global plans and regulatory submission deliverables for sustaining variationsSupport special projects as neededUtilize regulatory knowledge to prepare submission deliverables that will achieve desired resultsInterpret and apply emerging regulatory requirements to ongoing workEnsure identified standards and content requirements are met for regulatory submissionsTimely, actively support query responsesEngage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirementsInterface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).Maintain regulatory files in a format consistent with requirementsTrack status, quality/compliance and progress of regulatory documentationReview, edit and proofread regulatory documentation

Qualifications

Bachelor’s Degree or country equivalent in related scientific disciplineHigher degree/PhD will be an advantageSpecialist - Minimum of 5 years’ regulatory experience in RA or related healthcare environmentExperience operating in a regulated environmentAbility to operate in a matrixed environment and manage multiple activities, priorities and deadlinesExercise independent judgementScientific knowledge and ability to discuss technical matters with cross-functional team membersKnowledge of regulations and ability to communicate and applyAbility to identify compliance risks and escalate when necessaryDemonstrated leadership, coaching or mentoring skillsExcellent verbal and written English communication skills, suitable for multi-location working relationshipsDemonstrated teamwork and collaboration skillsAptitude for Attention to Detail

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.

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