Document Specialist
Company: ProPharma Group
Location: India (Hybrid / Remote depending on proximity to office)
Employment Type: Full-time
Experience Required: 3+ Years
Salary (India Estimate): ₹6 LPA – ₹12 LPA
Job Overview
ProPharma Group is hiring a Document Specialist to support regulatory document publishing and electronic submissions for pharmaceutical and biotech clients.
In this role, you will format, review, compile, and process regulatory documents while ensuring compliance with global regulatory standards and client specifications. The position focuses on high-quality document formatting, eCTD publishing, and regulatory submission support.
Key Responsibilities
Format and prepare regulatory documents in Microsoft Word and PDF according to client and regulatory guidelines.
Support electronic regulatory submissions such as IND, CTA, NDA, BLA, and MAA.
Convert and format documents for eCTD compliance, including bookmarks, hyperlinks, keyword linking, and document properties.
Compile regulatory reports and documentation required for regulatory submission packages.
Perform pre-publishing and post-publishing quality checks to ensure accuracy and compliance.
Prepare and transfer final documents for submission while coordinating with internal teams and clients.
Manage multiple document publishing projects simultaneously while meeting strict timelines.
Conduct peer reviews and quality checks for documents processed by team members.
Stay updated on regulatory publishing standards and industry best practices.
Required Qualifications
Minimum 3 years of experience in document publishing or regulatory document formatting.
Experience in pharmaceutical or biotech regulatory documentation preferred.
Strong command of English communication and writing.
Required Skills
Advanced expertise in Microsoft Word (complex formatting).
Strong experience with Adobe Acrobat and PDF editing tools.
Familiarity with eCTD publishing systems such as ISI Toolbox or Core Dossier.
Knowledge of regulatory guidelines such as:
ICH E3
ICH E6(R2)
ICH M4
EU MDR / IVDR
Strong project management, communication, and problem-solving skills.
Ability to manage multiple projects with strict regulatory timelines.
High attention to detail, accuracy, and quality standards.
Benefits
Employees at ProPharma Group may receive:
Competitive salary and performance incentives
Flexible hybrid work options
Health insurance and employee wellbeing programs
Career development and training opportunities
Inclusive and collaborative work environment
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