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.

The Regulatory Publishing Specialist is responsible for the formatting, publishing (PDF), eCTD compilation, review, and dispatch of regulatory submissions to Health Authorities. The Regulatory Publishing Specialist will work collaboratively with the Regulatory Affairs team along with project teams and other functional areas to ensure high quality submission content. This will be a busy position managing multiple submissions at the same time, reporting to the Manager of Regulatory Operations.

• Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements.
• Strong understanding and knowledge of New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) document format and content.
• Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing, and QC.
• Publishes electronic submissions in Electronic Common Technical Document (eCTD) for FDA. This may include source document formatting, internal and external hyperlinking, and bookmarks and sequence-level publishing.
• Support optimization of publishing best practices and submission standards in accordance with regulatory requirements.
• Prepare, publish, and submit regulatory dossiers to FDA.
• Responsible for the timely completion of assigned publishing tasks.
• Supports the implementation, maintenance, and continuous improvement of authoring and publishing systems and processes striving for publishing excellence.

• Bachelor's Degree, preferably in a scientific field such as biochemistry or biology, or relevant experience.
• At least 2-3 years in a regulatory publishing function.
• Extensive experience with Microsoft Word
• Understanding of publishing practices and related issues.
• Direct hands-on experience with the successful submission of eCTD dossiers.
• Previous Lorenz and Veeva (RIMVault) experience are required.

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 $80,000 to $110,000 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.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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 here and let us know the nature of your request along with your contact information.

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