🗂️ Document Specialist Job in India – Join ProPharma Group Today!
- 🏢 Company: ProPharma Group
- 📍 Location: India (Remote/Hybrid options available)
- 🎓 Eligibility: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences
- 🧪 Experience: 3+ Years
- 📝 Job Type: Full-Time | Regulatory Publishing
- 🔎 Verified: ✅ Verified Opportunity
🧬 About ProPharma Group
For over 20 years, ProPharma Group has supported the pharmaceutical, biotech, and medical device industries by delivering comprehensive regulatory and compliance consulting services. The company excels in areas such as clinical research, pharmacovigilance, and regulatory publishing.
📄 Job Overview
Job Title: Document Specialist
Job ID: JR7171
🧑💼 Key Responsibilities
- Prepare, format, and review regulatory documents for eCTD submissions (IND, NDA, BLA, MAA, CTA).
- Ensure compliance with ICH E3/E6(R2), EU MDR/IVDR, and other global guidelines.
- Use Adobe Acrobat and Microsoft Word for publishing, including hyperlinks, bookmarks, and formatting.
- Utilize eCTD tools like ISI Toolbox and Core Dossier to compile submission-ready files.
- Manage multiple projects while meeting timelines and maintaining accuracy.
✅ Required Skills
- Strong experience with Microsoft Word & Adobe Acrobat (Advanced)
- Hands-on knowledge of eCTD publishing tools
- 3+ years in pharmaceutical regulatory document preparation
- Detail-oriented and capable of handling tight timelines
- Bachelor’s degree in life sciences or related field
🎯 Why Join ProPharma?
- 🌍 Global Leader in Compliance & Regulatory Support
- 📈 Long-Term Career Growth
- 🤝 Inclusive & Innovative Work Environment
- 🧠 Training & Development Programs
📘 What is a Regulatory Document Specialist?
A Regulatory Document Specialist is a key professional in the pharmaceutical industry who ensures that all required documents for regulatory submissions (e.g., INDs, NDAs, CTAs) are correctly formatted, reviewed, and submitted. Their work ensures that companies comply with health authority regulations, such as those from the FDA, EMA, and CDSCO.
🚀 Career Scope in Regulatory Affairs
Regulatory Affairs offers long-term growth and excellent compensation in pharma. Professionals can move into senior document control, regulatory manager, or clinical compliance roles. Opportunities are expanding due to increasing global demand for faster drug approvals and safety compliance.
🛠 Skills Required for Regulatory Publishing Roles
- Strong command of Microsoft Office tools, especially Word and PDF editing
- Hands-on experience with eCTD tools like Lorenz DocuBridge, ISI Toolbox
- Attention to detail and ability to manage large document sets
- Basic knowledge of ICH guidelines and regional regulatory requirements
🏢 Top Companies Hiring Document Specialists
- ProPharma Group
- IQVIA
- Parexel
- Accenture Life Sciences
- Labcorp Drug Development
🔁 Similar Job Titles
- Regulatory Affairs Associate
- Clinical Document Specialist
- Regulatory Publishing Associate
- eCTD Submission Specialist
- Regulatory Compliance Analyst
📚 Suggested Courses to Grow Your Career
- eCTD Publishing Training – Pharma Learning Hub
- ICH Guidelines and Document Formatting – Coursera
- Adobe Acrobat Pro for Pharma Professionals – Udemy
❓FAQs
Q. Can a fresher apply for a Document Specialist job?
A. Most roles require 2–3 years of experience, but entry-level positions exist with strong software skills and certification.
Q. What tools are used for eCTD publishing?
A. Tools like ISI Toolbox, Lorenz DocuBridge, CoreDossier, and Extedo eCTDmanager are commonly used.
Q. What is the average salary of a regulatory publishing expert?
A. In India, mid-level professionals earn ₹6–12 LPA; international roles offer higher packages.
📌 Note Before You Apply:
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