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Regulatory Affairs, Senior Associate

Req # JR - 022487 Location Deerfield, Illinois, United States Job Category Regulatory Affairs Date posted 06/10/2020

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

Summary

Baxter is a global company dedicated to manufacturing and marketing products that save and sustain the lives of people with infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This position will be responsible for supporting all regulatory activities associated with product development, new registrations and optimal lifecycle management of the Baxter Renal Care peritoneal dialysis disposable/ancillary portfolio.This position will interface with business and cross-functional stakeholders to ensure that the commercial objectives are achieved.Specific activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project teams.

Essential Duties and Responsibilities

  • With direction, develop and execute regulatory project plans
  • Identify and elevate key areas of regulatory risk
  • Maintain awareness of regulatory requirements; identify relevant requirements
  • Maintain regulatory files in a format consistent with requirements
  • Participate as an active team member and provide regulatory advice to project teams as required
  • Respond to 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
  • Support regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and SOP’s
  • Represent or lead Regulatory Affairs in small project teams

Qualifications

  • Knowledge of regulations
  • Scientific knowledge
  • Project management skills
  • Manage multiple projects and deadlines
  • Ability to multitask and prioritize
  • Interpersonal and communication skills
  • Negotiation skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Cultural sensitivity
  • Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
  • Fluency in English required / other languages desirable
  • Bachelor’s Degree or country equivalent
  • Minimum of 2 years’ experience in RA or related discipline
  • Experience in a healthcare environment preferred

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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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