Job Description

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\xe2\x80\x94where your purpose accelerates our mission.

This position provide support to the Pharma RA team in review of technical documents and support in technical write-up needed for submission of high quality product dossiers in markets of US/EU/ANZ/Canada. The incumbent will perform other duties as assigned.

• Support the regulatory team for obtaining and maintaining registration filings (ANDA/NDA for US; ANDS/NDS for Canada and national, MRP/DCP registrations i.e New MAAs, Extensions, Renewals, Supplements, Variations, Transfers of Ownership, etc.)
• Review of technical documents like Specification/MOA/Stability protocol/Product Development report/Batch Mfg records, under supervision.
• Work collaboratively with senior members of the team in activities such as high quality technical write-up/dossier authoring as per project requirements.
• Collaborate with internal and external project team members for the collection, review and finalization of regulatory documents in a timely manner, under supervision.
• Provide support as needed in any related regulatory activities.
• Apply technical theories and principles to projects within area of expertise.
• Work according to appropriate standards and Global practices (e.g., Data Integrity, E&C, GQPs) guidelines.
• Maintenance of RA database for the responsible franchises in RIMS Tools.
• Ensure uniformity, consistency and quality in the scientific and administrative content of the regulatory documents.
• Disseminate the learnings and best practices at regular intervals across teams.
• Capable of identifying when to ensure line support required to provide additional guidance and direction
• Be a proactive member of the Regulatory team to ensure Baxter\xe2\x80\x99s continuing compliance with regulatory authorities.

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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