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Sr. Specialist, Global Regulatory Affairs – Publishing

5 years years
not specified
10 Sept. 3, 2025
Job Description
Job Type: Full Time Education: Bachelor’s Degree (or equivalent) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.