For over 20 years, ProPharma Group has been a trusted partner in the biotech, medical device, and pharmaceutical industries, helping companies bring innovative therapies to market. With expertise in regulatory sciences, clinical research, pharmacovigilance, and compliance, ProPharma provides end-to-end consulting solutions.
The company fosters a diverse, inclusive workplace where employees are encouraged to innovate and grow. If you’re looking for a dynamic career in regulatory document publishing, this is your opportunity!
Job Title: Document Specialist
Location: India (Remote/Hybrid options available)
Job Type: Full-time
Posted: Today
Requisition ID: JR 7171
Key Responsibilities:
- Format, review, and compile regulatory documents (Word & PDF) for eCTD submissions (IND, CTA, NDA, BLA, MAA).
- Ensure compliance with ICH E3/E6(R2), EU MDR/IVDR, and client-specific guidelines.
- Perform PDF conversions, adding bookmarks, hyperlinks, and keyword linking for regulatory compliance.
- Manage multiple publishing projects, ensuring timely and accurate submissions.
- Collaborate with clients and internal teams to resolve formatting and publishing issues.
- Conduct peer reviews and support process improvement initiatives.
Required Skills & Qualifications:
✔ Advanced Microsoft Word & Adobe Acrobat expertise
✔ Experience with eCTD publishing tools (ISI Toolbox, Core Dossier)
✔ 3+ years in regulatory document publishing (pharma/biotech preferred)
✔ Strong attention to detail, problem-solving, and project management skills
✔ Bachelor’s degree in life sciences or related field
Why Join ProPharma?
✅ Global leader in regulatory and compliance consulting
✅ Collaborative & innovative work environment
✅ Career growth and professional development opportunities
✅ Inclusive workplace that values diversity and equity
How to Apply
