Senior Regulatory Publishing Specialist
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Regulatory Affairs
Job ID: R-01334983
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking a Senior Regulatory Publishing Specialist to support the preparation and delivery of regulatory submission documents in compliance with local, regional, and ICH guidelines. The role focuses on electronic submissions, dossier management, and document publishing to ensure timely and high-quality regulatory review outcomes.
The Specialist will provide leadership and quality oversight, mentor junior staff, and work closely with internal project teams and external clients to deliver submission-ready documents that meet stringent regulatory standards.
Key Responsibilities
Prepare and publish electronic regulatory submissions (eCTD, modular appendices, CSRs, IBs) in compliance with regulatory guidance and sponsor requirements.
Maintain the document lifecycle for all submission components and ensure consistency, security, and regulatory compliance.
Act as a liaison with sponsors for submission-specific queries, providing guidance on electronic submission processes.
Lead project-specific processes for clients with unique technology requirements and ensure deliverables meet timelines and quality standards.
Provide mentorship and training to junior staff in electronic publishing practices, tools, and regulatory standards.
Evaluate publishing needs, identify potential risks or issues, and implement solutions independently or within a project team.
Ensure all published documents are consistent, accurate, and adhere to both internal and client quality standards.
Collaborate with cross-functional teams to deliver submission-ready documents efficiently and effectively.
Required Qualifications & Experience
Education: Bachelor’s degree or equivalent in a relevant scientific, technical, or regulatory field.
Experience:
Minimum 5+ years of experience in regulatory publishing within the pharmaceutical or CRO industry.
Proven expertise in electronic document management, eCTD publishing, and regulatory submission processes.
Technical Skills:
Strong working experience with Veeva Vault (binders, modular appendices).
Advanced proficiency in Microsoft Word (macros, templates, custom toolbars), Excel, Adobe Acrobat.
Experience with document publishing tools, electronic submission systems, and validation tools.
Skills & Competencies
In-depth knowledge of global regulatory requirements, FDA, EMA, PMDA, and ICH guidelines.
Expertise in clinical and regulatory document formatting, publishing, and submission-ready document preparation.
Strong analytical, editorial, and proofreading skills with attention to detail.
Ability to manage multiple complex projects simultaneously while adapting to changing priorities.
Strong organizational and planning skills, including long-range planning and timeline management.
Ability to exercise independent judgment in evaluating methods, templates, and document presentation.
Effective interpersonal and communication skills for collaboration with internal and external stakeholders.
Ability to learn and implement new publishing technologies efficiently.
Work Schedule & Environment
Standard working hours: Monday to Friday
Flexible, fully remote work option with collaboration across global teams.
Why Join Thermo Fisher Scientific
At Thermo Fisher Scientific, we are driving innovation in clinical research by delivering high-quality regulatory solutions globally. As a Senior Regulatory Publishing Specialist, you will play a critical role in ensuring compliance, quality, and operational excellence, contributing directly to patient-centric drug development initiatives.
SEO Keywords Optimized: Regulatory Publishing Jobs Remote India, eCTD Publishing Careers, Senior Regulatory Affairs Specialist, Clinical Research Publishing Jobs, Pharmaceutical Regulatory Submission India.
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