📄 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
Apply Now
🏢 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.
🔗 Learn more: https://www.jnj.com
🧾 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.
🎯 Key Responsibilities
📄 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.
🔄 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.
📊 Project Leadership & Monitoring
Lead multiple document projects with proactive oversight of:
Timelines
Scheduling
Strategy alignment
Track submission document progress across systems.
📚 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
🤝 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.
👥 Key Relationships
🔹 Internal Stakeholders
Manager
Regulatory document specialists
Cross-functional teams (Clinical, Regulatory, Data Management, Safety, Quality)
🔹 External Stakeholders
Contractors or external publishing vendors (as needed, under supervision)
🎓 Education & Experience Requirements
✅ Education
Preferred: Bachelor's degree (BS/BA)
Alternate Path: 5–8 years of relevant experience without a formal degree
✅ 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
🧠 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
🌍 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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