Senior Specialist, Regulatory Affairs

Responsibilities

• 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.
• 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

Requirements

• 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.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
• #LI-RS1
• US Benefits at Baxter (except for Puerto Rico)
• This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for

Benefits

Additional Information

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. Your role at Baxter 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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Baxter? Share your experience