Are you a Life Sciences graduate with expertise in regulatory document publishing? ProPharma Group is hiring Document Specialists for its regulatory team in India. This is a full-time remote or on-site opportunity for professionals with 3+ years of experience in eCTD submissions, regulatory formatting, and pharmaceutical compliance.
Job Description
Key Responsibilities
- Format, review, and compile regulatory documents (Word & PDF) for INDs, CTAs, NDAs, BLAs, and MAAs.
- Ensure compliance with eCTD standards, including bookmarks, hyperlinks, metadata, and style guides.
- Convert Word files to submission-ready PDFs using Adobe Acrobat and eCTD publishing tools.
- Perform quality checks to ensure accuracy and regulatory compliance.
- Collaborate with clients and internal teams to meet strict submission deadlines.
- Manage multiple projects while maintaining high attention to detail.
- Stay updated on ICH guidelines, EU MDR/IVDR, and industry best practices.
Required Skills
✔ Advanced MS Word (formatting, templates, styles)
✔ Expertise in Adobe Acrobat (PDF conversion, eCTD plugins)
✔ Hands-on experience with eCTD publishing tools (ISI Toolbox, Core Dossier, etc.)
✔ Strong project management and communication skills
✔ Ability to work under tight deadlines with high accuracy
✔ Life Sciences or Pharma background preferred
Qualification Criteria
- Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or related field
- Minimum 3 years in regulatory document publishing
- Experience with IND, CTA, NDA, BLA, MAA submissions (preferred)
- Knowledge of ICH guidelines, EU MDR/IVDR, and regulatory SOPs
About ProPharma Group
ProPharma Group is a global leader in regulatory sciences and pharmaceutical consulting, supporting drug development from early-stage research to post-market compliance. With a focus on innovation and regulatory excellence, ProPharma offers a collaborative work environment with opportunities for career growth and skill development.
Why Join ProPharma Group?
✅ Work with top pharmaceutical and biotech clients
✅ Remote or on-site flexibility (based on role)
✅ Competitive salary & benefits
✅ Inclusive and growth-oriented culture
✅ Exposure to global regulatory submissions
How to Apply
Interested candidates can apply through the official ProPharma careers portal:
