Senior Specialist, Regulatory Affairs

Baxter International Inc.•Deerfield, IL

1d•$88,000 - $121,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a scientific, life sciences, or related technical field
2+ years of regulatory experience
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.

Nice To Haves

Pharmaceutical industry experience preferred
Knowledge of regulations for FDA submission preferred.

Responsibilities

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.
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

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits