Sr Specialist, Regulatory Affairs

This is where  your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

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.

Job Role : Sr. Specialist, Global Regulatory Affairs Publishing

Job Location : Whitefield, Bangalore

Essential Duties and Responsibilities

• Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions.
• Responsible for managing regulatory Product Life Cycle activities for electronic Submissions.
• High Proficiency in managing end-to-end RIMS-Veeva Vault for eCTD / NeeS regulatory submissions.
• Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal.
• Perform quality control (QC) checks to ensure high quality submission with zero deficiency.
• Assist with the update of the publishing processes and SOPs.
• Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs.
• Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities.
• Will have to work independently with minimal support.
• Proactive tracking of submission status and progress of regulatory filings.
• Maintenance of Regulatory systems, trackers and databases.

Qualifications