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:

The Regulatory Affairs Specialist is responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global Baxter’s products.

What you'll be doing:

• Supports regulatory project plan execution

• Maintain awareness of regulatory requirements and ensure continued learning

• Maintain regulatory files in a format consistent with requirements

• Participate as an active team member of project teams as required

• Compile and prepare responses to questions from regulatory authorities according to plan

• Edit and proofread regulatory documentation

• Assist in preparation and review of labeling, SOP’s, and other departmental documents

• Compile under supervision regulatory documents for submission

• Track status and progress of regulatory documentation

• Understand Regulatory Affairs' position in small project teams

What you'll bring:

• Bachelor’s degree or country equivalent in a relevant scientific discipline

• Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification

• Regulatory experience (not mandatory) preferably within a healthcare environment

• Scientific knowledge

• Administrative and project management skills

• Ability to contribute to multiple projects from a regulatory affairs perspective

• Ability to multitask and prioritize

• Interpersonal and communication skills

• Technical system skills (e.g. word processing, spreadsheets, databases, online research)

• Proofreading and editing skills

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $52,800 to $132,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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

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