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Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Summary:

Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for pharmaceutical products and the preparation of documents/packages for regulatory submissions and keep registration records in applicable RA systems.

Essential Duties and Responsibilities:

Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations aligned with business strategy.  Establish appropriate communication within RA and other functions primarily at project levelEnsure project teams and business objectives and deliverables are aligned with regulatory strategyMonitor applicable regulatory requirements; assure compliance with Baxter and external standardsReview promotional material and SOPs for compliance with local and global regulations Review, edit and proofread, track status and progress regulatory documentationLocal label content management as per the regulatory requirements following internal SOPs.Participate as an active team member of regional project teams as required

Qualifications:

Sound basis of Regulatory and scientific knowledgeAbility to manage complex projects and timelines in a matrix team environmentStrong oral and written communication and presentation skillsAbility to identify compliance risks and escalate when necessary Demonstrated interpersonal skills including strong negotiation skillsProficiency in English

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.

Bachelor’s degree or more in pharmacy with a minimum of 8 years regulatory experience with a pharmaceutical company, CRO, or similar organization. Higher degree/PhD will be an advantage.

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.

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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