Regulatory Publishing Specialist
Location: Remote, India
Job ID: R-01319205
Job Type: Full-time
Category: Clinical Research
Shift: Standard (Mon–Fri)
Estimated Salary: ₹6 – ₹10 LPA (based on CRO industry benchmarks for similar roles in India)
Position Overview:
Thermo Fisher Scientific is hiring a Regulatory Publishing Specialist to join its clinical research division under the PPD® portfolio. In this fully remote role, you'll support the preparation of client electronic submission deliverables and regulatory dossiers, ensuring compliance with global regulatory and ICH guidelines. You’ll be an integral part of the regulatory publishing process, helping streamline drug approvals and clinical development worldwide.
Key Responsibilities:
Coordinate and manage electronic submission deliverables supporting global regulatory compliance
Prepare electronic document outputs aligned with sponsor and regulatory agency requirements
Ensure final deliverables meet eCTD standards and applicable local and international guidelines
Review documents for completeness and formatting accuracy; perform quality control (QC)
Work with cross-functional teams and regulatory affairs teams to ensure timely submission
Assist in developing project-specific submission workflows for unique sponsor requirements
Act independently within projects to assess and deliver publishing tasks efficiently
Address and resolve document issues to support regulatory milestones
Required Qualifications:
Bachelor’s degree in science, technology, or a related field
2+ years of experience in regulatory publishing or a closely related field
Experience using publishing software (e.g., Lorenz DocuBridge, EXTedo, or similar tools)
Experience working with eCTD, NeeS, and other electronic submission formats
Key Skills & Abilities:
Deep knowledge of global regulatory requirements and ICH guidance
Proficient in MS Word, Excel, Adobe Acrobat, and document formatting
Familiarity with eCTD validation and viewing tools
Strong skills in troubleshooting electronic document issues and formatting errors
Excellent editing, proofreading, and quality assurance capabilities
Strong analytical, organizational, and time management skills
Independent, self-motivated, and adaptable to changing priorities
Good understanding of medical terminology and submission lifecycle
Strong interpersonal skills with the ability to liaise with global teams
Why Join Thermo Fisher Scientific?
Contribute to life-saving clinical research around the world
Work in a diverse, inclusive, and innovation-driven environment
Access a wide range of professional development and learning opportunities
Enjoy flexible remote work with competitive compensation and benefits
Be part of a mission to make the world healthier, cleaner, and safer
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