Job Description

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

  • Bachelor’s Degree or equivalent with 5 or more years’ experience in regulatory electronic document management and/or electronic submission publishing.
  • Must possess strong analytical thinking, and excellent organizational and communication skills.
  • Candidate must be able to work in a team-oriented, fast-paced environment.
  • Strong technical skills (ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases).
  • Demonstrated leadership, coaching or mentoring skills.
  • Excellent verbal and written English communication skills, suitable for multi-location working relationships.
  • Demonstrated teamwork and collaboration skills.

    • Apply for this Position

    Ready to join ? Click the button below to submit your application.

    Submit Application