Job Description

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\xe2\x80\x94where your purpose accelerates our mission. Summary: Under general supervision responsible for monitoring regulations and guidance for assigned submission types and coordinating and preparing standard submissions (i.e. US Drug Annual Reports) on behalf of Global Regulatory Leads. Essential Duties and Responsibilities:

• Prepare and compile assigned standard submissions on behalf of Global Regulatory Lead within timelines required by health authority
• Maintain awareness of regulatory requirements and ensure continued learning
• Maintain regulatory files in a format consistent with requirements
• Participate as an active team member of project teams as required
• Edit and proofread regulatory documentation
• Track status and progress of regulatory documentation
• Assist in preparation, review and maintenance of role-based deliverables
• Participate in other projects as assigned

Qualifications:

• Knowledge of regulations
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills

Technical system skills (e.g. word processing, spreadsheets, databases, online research)

• Proofreading and editing skills

Education and/or Experience: Bachelor\'s degree or country equivalent in relevant scientific discipline. Suitable candidates with a non-scientific degree may be accepted and undertake further training. Regulatory experience (not mandatory) preferably within a healthcare environment Reasonable Accommodations 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. 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. 110004