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 global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Support regulatory activities relating to global products/projects within the Pharma GBU.

Essential Duties:

• With direction, develop and execute regulatory project plans.

• Identify and elevate key areas of regulatory risk

• Maintain regulatory files in a format consistent with requirements

• Maintain awareness of regulatory requirements; identify relevant 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:

• 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.

• 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

• Your employment is conditional upon being fully vaccinated for COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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 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.

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