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Principal Regulatory Affairs Specialist

Req # JR - 053139 Location Bloomington, Indiana, United States Job Category Regulatory Affairs Date posted 11/30/2021

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Summary

Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for product(s), and communication of general regulatory requirements in support of licensing of Baxter and/or Pharma Partner products. Serves as a consultant to managers and manages regulatory activities relating to specific global portfolio of therapeutic products/projects.

Essential duties

  • Initiate and develop complex regulatory project plans
  • Identify & prioritize key areas of regulatory risk
  • Provide regulatory advice to project teams
  • Respond to complex questions from regulatory authorities within strict timelines
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Maintain and update existing regulatory authorizations
  • Manage regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and SOPs
  • Lead or represent Regulatory Affairs in project teams
  • Provide guidance and coaching for areas of responsibility to lower level team members
  • Monitor applicable regulatory requirements
  • Create and maintain regulatory files in a format consistent with requirements
  • Collaborate and support global regulatory strategies and submissions
  • Provide regulatory assessment of changes impacting globally registered products

Qualifications

  • Bachelor’s degree or country equivalent in a scientific discipline
  • Minimum of 5 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization.
  • Applications knowledge including NDA's, ANDA's, BLA's, and MAA's preferred
  • Experience with FDA regulations
  • Scientific knowledge
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong interpersonal and communication skills
  • Strong negotiation skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Ability to work effectively in multinational/multicultural environment
  • Ability to identify compliance risks and escalate when necessary

#LI-BAXGEN

#IND-USOPS

Equal Employment Opportunity

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

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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