Senior Specialist, Regulatory Affairs

This is where
your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

The Senior Specialist resides within the Global Regulatory Affairs Systems Group. This group owns the Regulatory Information Management (RIM) and Advertising and Promotions (Ad Prom) process, and the system that enables the process (Veeva RIM and Promo Mats). An ideal candidate will have strong working experience with RIM and Ad Prom systems to understand the current business process.

• Under general supervision, responsible for Veeva RIM, Promo Mats system ownership
• Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities.
• Working with project teams on various data initiatives, addressing data challenges and gaps in current system.
• Identify areas for improvement/modification.
• Compile regulatory documents for FDA 2253 submission. Which includes tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements.
• Develop training material and liaise with cross function teams.
• Understand internal global processes supporting Regulatory systems.
• Coordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools; manages and tracks communications, metrics, and reporting-related processes
• Develops, executes and implements business processes for data integration, maintenance and remediation. Conducts impact assessments, develops strategies for implementing and maintaining data quality

• Bachelor’s degree in a scientific, life sciences, or related technical field
• 2+ years of regulatory experience
• Pharmaceutical industry experience preferred
• Strong understanding of Veeva software (RIM and Promo Mats) systems.
• Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines.
• Strong analytical skills, including digital competency.
• Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel).
• Proofreading and editing skills.
• Ability to contribute to multiple projects from a regulatory affairs perspective.
• Ability to multitask and problem solve.
• Knowledge of regulations for FDA submission preferred.

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 $88,000 - $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based 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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes…