Job Title: Sr. Specialist, Global Regulatory Affairs – Publishing
Job Requisition Number: JR - 183703
Location: Whitefield, Bengaluru, Karnataka, India
Department: Regulatory Affairs
Date Posted: August 30, 2025
About Baxter
At Baxter, we believe that everyone deserves a chance at a healthy life. Since our founding in 1931, this principle has guided us as we redefine healthcare delivery—today, tomorrow, and beyond.
United by our Mission to Save and Sustain Lives, Baxter fosters a culture of courage, trust, and collaboration. Our employees are empowered to make a meaningful impact and are held accountable for achieving exceptional results.
At Baxter, you’ll find more than just a job—you’ll find purpose and pride.
Position Overview
The Sr. Specialist, Regulatory Affairs – Publishing is responsible for end-to-end regulatory submission publishing for both drug and device portfolios. This includes document management, submission dispatch, and lifecycle maintenance via global regulatory platforms and systems.
Key Responsibilities
Regulatory Submission Management
Publish, review, archive, and dispatch eCTD, NeeS, or paper regulatory submissions for both devices and drugs.
Manage product lifecycle submissions and updates in Veeva Vault RIMS and related publishing systems.
Ensure compliance and completeness of submission content across formats.
Gateway and Dispatch Handling
Expertise in using regulatory authority gateways for submission dispatch:
FDA ESG
MHRA Portal
CESP
EMA Portal
Quality & Compliance
Perform quality control (QC) of all submissions to ensure zero-deficiency submissions.
Assist in the review and updating of submission processes, SOPs, and best practices.
Collaboration & Support
Coordinate with Global and Regional Regulatory teams to align regulatory activities with business needs.
Support cross-functional teams in managing product registrations and submission planning.
Tracking & Documentation
Proactively track submission status and timelines.
Maintain accurate records in regulatory systems, trackers, and databases.
Required Qualifications & Skills
Education:
Bachelor’s Degree (or equivalent)
Experience:
Minimum 5 years of experience in regulatory electronic document management and/or electronic submission publishing.
Technical Skills:
Proficiency in:
ISI Toolbox, ISI Publisher, eCTDXpress, Adobe Acrobat, Microsoft Word/Excel, ISI Writer
Strong knowledge of Veeva Vault RIMS
Experience working in fast-paced, team-oriented environments
Core Competencies:
Strong analytical thinking, organizational, and communication skills
Demonstrated leadership, coaching, or mentoring abilities
Excellent verbal and written English communication skills
Proven ability to work independently with minimal supervision
Workplace Location
Baxter (India) Pvt. Ltd.
Tower B, 16th Floor
Whitefield, Bengaluru – 560048
Karnataka, India
Equal Opportunity Employer
Baxter is an equal opportunity employer. We evaluate qualified applicants without regard to:
Race, color, religion, gender
Age, sexual orientation, gender identity or expression
National origin, veteran status, or disability
Reasonable Accommodations
If you require a reasonable accommodation due to a disability or medical condition during the application or interview process, click here to submit your request and contact details.
Recruitment Fraud Warning
Baxter has identified fraudulent employment scams. We never request personal or financial information via unauthorized communication channels. Learn more in our Recruitment Fraud Notice.
How to Apply
Click the "Apply Now" button on the job posting page to submit your application.
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