Global Regulatory Affairs Publishing Specialist

Baxter International Inc.•Round Lake, IL

5d•$72,000 - $99,000•Hybrid

About The Position

At Baxter, the Global Regulatory Affairs Publishing Specialist supports the preparation, publishing, and timely delivery of regulatory submissions across global markets. The role works with cross-functional teams on product registrations and lifecycle management activities while maintaining compliance with health authority requirements and electronic submission standards. The specialist manages regulatory submission preparation for major markets, conducts technical validation, and resolves publishing errors before dispatch. The role also supports initial applications and lifecycle submissions, helps integrate products into regulatory operations processes, compiles technically compliant submission components, and manages document formatting. The specialist may represent Global Publishing on project teams responsible for submission-document timelines, partners with functional groups inside and outside the department, and provides system, process, development, and training support as needed. The position follows Baxter’s flexible workplace policy, which requires a minimum number of onsite days each week. Applicants must be authorized to work for any U.S. employer; visa sponsorship is unavailable. The estimated base salary is $72,000–$99,000 annually, with individual pay varying based on location, skills, expertise, experience, and other factors.

Requirements

Bachelor’s degree or an equivalent combination of education and relevant professional experience.
Hands-on experience with pharmaceutical submissions and eCTD submissions, including INDs, BLAs, NDAs, and ANDAs, and device submissions, including eCopy and eSTAR.
Experience with electronic publishing, document, or data management systems, such as Veeva/RIM, ISI Toolbox, or eCTD Xpress.
Familiarity with electronic submission regulations and guidance, including 21 CFR Part 11.
Sound basis of regulatory knowledge.
Ability to manage complex projects and timelines in a matrix team environment.
Strong oral and written communication and presentation skills.
Strong interpersonal and negotiation skills.
Ability to independently identify compliance risks and escalate when necessary.
Authorization to work for any employer in the United States; Baxter is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

1–3+ years of regulatory publishing or regulatory operations experience in the pharmaceutical or medical device industry.

Responsibilities

Manage preparation of regulatory submissions for major markets, including the United States, European Union, Canada, Australia, and other global regions.
Perform technical validation and resolve publishing errors before dispatch.
Support initial applications and lifecycle submissions.
Drive integration and transition of products into regulatory operations processes.
Compile technically compliant submission components and manage document formatting.
May represent Global Publishing on project teams driving timelines for submission document deliverables.
Partner with functional peer groups inside and outside the department.
Provide system and process support, development, and training when necessary.
Identify compliance risks independently and escalate when necessary.

Benefits

Medical and dental coverage starting on day one.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence and paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.