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Sr Mgr, Regulatory Affairs (Pharmaceutical)

Req # JR - 118301 Location Deerfield, Illinois, United States Job Category Regulatory Affairs Date posted 11/14/2023

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. 

Your role at Baxter

The RA Sr. manager will be responsible for defining global regulatory strategies and submissions in support of new products, complex products, and existing global market authorizations (including Generics, 505(b)(2)s, and marketed 505(b)(1) NDAs)

What will you be doing:

  • Initiate, manage and maintain operational activities in support of new and existing marketing authorizations - Plan and manage sophisticated projects and prioritize workload
  • Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
  • Maintain appropriate communication within the RA function, SBU marketing, and other functions primarily at the project team level
  • Communicate proactively and report to regulatory authorities
  • Evaluate technical and scientific information, identify deficiencies, implement and complete strategies to remediate risks
  • Assess impact of new regulations and provide feedback.
  • Set team, group, or service objectives to ensure they align with the Regulatory strategy
  • Provide technical and strategic feedback for regulatory decisions
  • May manage budget at country level
  • May provide direct supervision of individuals including mentoring, performance management and staffing decisions

What will you bring?

  • Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 7 years experience in RA, including managing people or projects.
  • Higher degree/PhD will be an advantage. -
  • Expert Regulatory knowledge. - Scientific Knowledge
  • Ability to coordinate multiple projects in a matrix team environment
  • Demonstrated excellent interpersonal and teamwork skills, including diplomacy to negotiate conflicting priorities.
  • Excellent oral and written communication and presentation skills.
  • Ability to accomplish results through others.
  • Ability to lead, mentor, and empower others.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $128,000 to $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

#LI-BAXGEN

#IND-CA

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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