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Principal Specialist, Global Regulatory - Renal Care

Req # JR - 034944 Location Deerfield, Illinois Job Category Regulatory Affairs Date posted 02/23/2021

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. 

This candidate will be responsible for the development and implementation of global regulatory strategies, obtaining and maintaining marketing authorizations for pharmaceutical product(s) within the assigned portfolio, and communication of general regulatory requirements in support of licensing of Baxter’s products. Additionally, this person will be responsible for providing on-market regulatory support for currently registered global products and managing regulatory activities relating to the assigned global portfolio of products. 

Duties and Responsibilities

  • Create and maintain pharmaceutical registration files according to regulatory requirements in the US, EU, and rest of world. 
  • Compile and submit, in a timely manner, regulatory documents according to applicable regulatory requirements.
  • Respond to complex questions from regulatory authorities within strict timelines and coordinate cross-functional input as required.
  • Lead or represent Regulatory Affairs in project teams.
  • Initiate, develop, and execute complex regulatory project plans and provide regulatory advice to project teams.
  • Identify and prioritize key areas of regulatory risk.
  • Conduct and coordinate change control regulatory assessments, including direct responsibility for completing US / EU post-market change assessment.
  • Manage regulatory activities relating to specific portfolio of products/projects (product owner)
  • Responsible for product labeling development and lifecycle management

Qualifications

  • Bachelor’s degree required.
  • Minimum of 5 years regulatory experience (or equivalent) required within a pharmaceutical company or similar organization / regulated industry.
  • U.S. drug submission experience (i.e., content authoring of Module 3, labeling development, DMF maintenance, etc.) is required.
  • Ability to work effectively in a multi-national / multi-cultural environment and across time zones as required.
  • Ability to manage multiple projects and deadlines effectively.
  • Excellent interpersonal and communication skills and project management / organizational skills required.
  • Ideal candidate will also possess working knowledge of medical device registration / CE marking.

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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.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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