๐ Job Title: Senior Analyst – Document Publishing
Function: Regulatory Affairs Group
Sub-function: Regulatory Product Submissions and Registration
Job Category: Senior Analyst, Regulatory Product Submissions and Registration (P6)
Location: Mumbai or Bangalore, India
Work Pattern: Fully Onsite
Date Posted: August 28, 2025
Requisition Number: R-026368
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๐ข About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Through our expertise in Innovative Medicine and MedTech, we deliver smarter, less invasive, and more personal solutions to advance global health. With a 130-year legacy, we remain committed to transforming healthcare for humanity.
๐ Learn more: https://www.jnj.com
๐งพ Role Overview
As a Senior Analyst – Document Publishing, you will serve as a key liaison between the authoring community and regulatory operations teams. You will ensure the delivery of submission-ready documents, maintain high quality and compliance standards, and lead process improvements within document publishing for regulatory submissions.
๐ฏ Key Responsibilities
๐ Document Publishing & Process Management
Serve as the single point of contact for the authoring community for document publishing support.
Coordinate operational aspects of document-level support:
Resource planning
Scheduling
Gap resolution
Ensure submission-ready documentation per global regulatory standards.
Apply appropriate submission standards, requirements, and policies to comply with health agency guidelines.
Drive process improvements to reduce inefficiencies and improve quality.
๐ Cross-functional Collaboration
Collaborate with:
Regulatory Affairs
Clinical teams
Data management
Safety and quality teams
Promote understanding of end-to-end submission processes and interdependencies.
๐ Project Leadership & Monitoring
Lead multiple document projects with proactive oversight of:
Timelines
Scheduling
Strategy alignment
Track submission document progress across systems.
๐ Training & Vendor Management
Assist in training users on new processes or publishing software.
Support vendor alliance management:
Monitor external vendor quality
Contribute to vendor work orders
๐ค Mentoring & Process Ownership
Coach/mentor junior staff on document processing procedures.
Provide peer review and quality checks on submission documents.
Participate in or lead internal working groups to improve document publishing processes.
๐ฅ Key Relationships
๐น Internal Stakeholders
Manager
Regulatory document specialists
Cross-functional teams (Clinical, Regulatory, Data Management, Safety, Quality)
๐น External Stakeholders
Contractors or external publishing vendors (as needed, under supervision)
๐ Education & Experience Requirements
โ Education
Preferred: Bachelor's degree (BS/BA)
Alternate Path: 5–8 years of relevant experience without a formal degree
โ Experience
Minimum 4 years of experience in regulatory document processing within the pharmaceutical industry
Expertise in:
Electronic document publishing tools
Document management systems
Word processing and formatting standards
Strong organizational and communication skills
Experience managing multiple projects and teams
๐ง Skills & Competencies
Mastery of Microsoft Word and industry-standard document tools
Familiarity with eCTD publishing and regulatory submission standards
Strong interpersonal, time management, and stakeholder coordination skills
Ability to lead and mentor junior colleagues
๐ Why Join Johnson & Johnson?
At J&J, you’ll be part of a company that’s revolutionizing health with science and compassion. Join a team where your expertise directly supports global patient access to innovative therapies.
We are an equal opportunity employer and celebrate diversity and inclusion in our workforce.
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