Regulatory Affairs Senior Expert

2 weeks ago

Deerfield Beach, Florida, United States Baxter Healthcare Corporation Full time
Join Baxter Healthcare Corporation
At Baxter, our mission is to save and sustain lives. Every role within our organization contributes to making a positive impact on patients globally.

We take pride in knowing that our efforts lead to improved health outcomes for millions.

Our innovative products and therapies are utilized in hospitals, clinics, and homes around the world. With over 85 years of pioneering advancements in medical technology, we foster an environment where collaboration and success thrive.
This is your opportunity to make a meaningful contribution at the intersection of healthcare and innovation.
Your Role
The Senior Expert in Regulatory Affairs will be a vital part of the Global Regulatory Affairs, Advertising and Promotions Group.

This team is responsible for overseeing the global Advertising and Promotions (Ad Prom) process, along with managing the associated system (Veeva PromoMats).

In this role, you will create submission packages for promotional materials intended for FDA review using Veeva PromoMats, while also managing system administration and configuration.

The ideal candidate will possess back-end experience with Ad Prom systems or have a background in Information Technology or Systems Administration within a life sciences context.

Key Responsibilities
Under general supervision, you will:
  • Manage Veeva PromoMats, Tableau, and regulatory documentation for FDA submissions.
  • Execute system updates in Veeva PromoMats, including workflows, configurations, and lifecycle management.
  • Identify and implement areas for improvement.
  • Compile regulatory documents for FDA submission, with a preference for eCTD experience.

Your responsibilities will also include:

  • Tracking the status and progress of regulatory documentation.
  • Reviewing, editing, and proofreading regulatory documents.
  • Actively participating in project teams as needed.
  • Maintaining regulatory files in compliance with established requirements.
  • Developing training materials and collaborating with cross-functional teams.
  • Understanding the internal global processes related to Advertising and Promotion.
Qualifications
To be successful in this role, you should have:
  • A Bachelor's degree or equivalent.
  • A minimum of 3 years of experience in the pharmaceutical industry, with at least 1 year in regulatory affairs or a concentration in IT within life sciences or a related field.
  • Familiarity with Veeva software (PromoMats or RIM) and Zinc software design.
  • Knowledge of Tableau software design.
  • Strong written and verbal communication skills, with the ability to organize, prioritize, and meet deadlines.
  • Excellent analytical skills and digital competency.
  • Technical proficiency in databases, XML, and Microsoft Office 365 (including SharePoint, Power Automate, and Excel).
  • Strong proofreading and editing abilities.
  • The capacity to contribute to multiple projects from a regulatory perspective.
  • Ability to multitask and solve problems effectively.
  • Familiarity with FDA submission regulations is preferred.
Workplace Flexibility
Baxter is dedicated to providing flexible work arrangements. Our policy includes a minimum of 3 days a week onsite, promoting collaboration and connection among team members.
Compensation
We recognize that compensation is a significant consideration in your career decisions.

Baxter is committed to equitable pay practices. The salary range for this position is $80,000 to $110,000, along with an annual incentive bonus.

The actual salary may vary based on factors such as relevant skills, experience, time in the role, business line, and geographic location.

Equal Opportunity Employer
Baxter is an equal opportunity employer, evaluating qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status, or any other legally protected characteristic.

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