ProPharma Hiring Document Specialist – Regulatory eCTD Publishing

ProPharma Hiring Document Specialist – Regulatory eCTD Publishing | 3+ Years Experience | India

ProPharma is recruiting for the position of Document Specialist in India for a full-time role supporting global regulatory publishing activities. This opportunity is ideal for professionals with a minimum of 3 years of experience in regulatory document formatting, eCTD publishing, and electronic submission support across IND, CTA, NDA, BLA, and MAA applications. If you have advanced expertise in Microsoft Word formatting, Adobe Acrobat, and regulatory submission systems, this role offers strong exposure to global pharmaceutical and biotech regulatory operations.

With increasing global regulatory scrutiny and digitization of submission processes, skilled document publishing professionals are essential in ensuring compliant, high-quality regulatory submissions that support faster drug approvals and lifecycle management.

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Company Overview

For over 20 years, ProPharma has partnered with pharmaceutical, biotechnology, and medical device companies to accelerate the development and approval of innovative therapies. Through its advise-build-operate model, the company supports clients across the complete product lifecycle — from early development and clinical research to regulatory approval, pharmacovigilance, quality compliance, and R&D technology solutions.

ProPharma is widely recognized for its deep expertise in regulatory sciences, electronic submissions, medical writing, and regulatory operations. The organization works on high-profile global drug and device programs, helping clients reduce regulatory risk, maintain compliance with ICH and regional guidelines, and achieve timely market authorization.

The Document Specialist role directly contributes to global submission excellence by ensuring that regulatory documents meet strict formatting, publishing, and eCTD compliance standards required by US FDA, EMA, and other health authorities.

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Job Role & Responsibilities

As a Document Specialist, you will support electronic regulatory submissions by formatting, compiling, reviewing, and publishing high-quality documents in accordance with global regulatory standards and client specifications.

Regulatory Document Formatting & Publishing

• Support electronic submission of regulatory applications including IND, CTA, NDA, BLA, and MAA.
• Format and review Microsoft Word documents according to client style guides and regulatory specifications.
• Convert documents to PDF and ensure compliance with eCTD requirements, including bookmarks, hyperlinks, keyword linking, and document properties.
• Compile complete regulatory dossiers and ensure all required documentation is included within defined timelines.
• Publish regulatory documents in eCTD format and conduct thorough pre- and post-publishing quality checks.

Regulatory Compliance & Standards

• Adhere to ICH guidelines such as E3, E6(R2), M4, and applicable EU MDR/IVDR requirements.
• Ensure compliance with client SOPs, internal processes, and global regulatory documentation standards.
• Maintain familiarity with evolving regulatory publishing practices and submission requirements.

Project & Client Coordination

• Manage multiple publishing projects simultaneously while maintaining strict timeline adherence.
• Communicate directly with clients to ensure clarity, accuracy, and timely delivery of submissions.
• Support document routing, review workflows, and approval processes prior to submission.
• Perform peer quality review of documents processed by other team members.
• Escalate potential risks or concerns proactively to line managers or client oversight managers.

Continuous Improvement & Team Participation

• Participate in process improvement initiatives and departmental knowledge-sharing sessions.
• Maintain a proactive, growth-oriented mindset while adapting to new regulatory tools and digital publishing platforms.
• Occasionally support extended working hours based on submission deadlines and client requirements.

This position plays a critical role in ensuring regulatory submission readiness, document integrity, and compliance-driven publishing accuracy across global pharmaceutical markets.

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Eligibility / Qualifications

Educational Background

Relevant degrees may include: B.Pharm, M.Pharm, PharmD, BSc Life Sciences, MSc Life Sciences, MSc Biotechnology, MSc Microbiology, MSc Clinical Research, Diploma or Certification in Regulatory Affairs, Pharmaceutical Documentation, or Clinical Data Management.

Experience

• Minimum 3 years of experience in regulatory document publishing and formatting.
• Hands-on exposure to INDs, CTAs, NDAs, BLAs, MAAs, and other global submission types preferred.
• Experience working in pharmaceutical, biotech, or regulatory consulting environments.

Key Technical Skills

• Advanced Microsoft Word formatting expertise (templates, styles, section breaks, TOC management).
• Strong knowledge of Adobe Acrobat and plug-in tools.
• Experience with eCTD publishing systems such as ISI Toolbox, Core Dossier, or similar platforms.
• Understanding of document management systems and workflow approval processes.

Core Competencies

• Excellent written and verbal communication skills in English.
• Strong attention to detail and quality control mindset.
• Ability to manage multiple projects under strict submission deadlines.
• Strong analytical and problem-solving capabilities.
• Ability to work independently while collaborating effectively within cross-functional teams.

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Location & Employment Details

• Location: India (Remote/Hybrid model supported based on proximity to office locations)
• Employment Type: Full-time
• Job Requisition ID: JR 9085

ProPharma supports flexible working models, including remote and hybrid arrangements. Candidates located near office facilities may be encouraged to adopt a hybrid model in alignment with team requirements.

Salary details are not publicly disclosed. Compensation is aligned with industry benchmarks for regulatory publishing and document management professionals within global life sciences consulting firms.

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Application Process

Interested candidates can apply directly through ProPharma’s official career portal using the link below:

Apply Here: https://propharmagroup.wd1.myworkdayjobs.com/ppgcareers/job/India/Document-Specialist_JR9085?source=LinkedIn

All applications are personally reviewed by ProPharma’s recruitment team. The organization does not rely on automated AI screening tools, and every applicant receives a formal outcome update.

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Frequently Asked Questions (FAQs)

1. Is prior eCTD publishing experience mandatory?

Yes, hands-on experience with eCTD formatting and publishing workflows is essential for this role.

2. What regulatory guidelines should candidates be familiar with?

Candidates should have knowledge of ICH E3, E6(R2), M4 guidelines, as well as US FDA and EMA submission standards.

3. Is pharmaceutical industry experience required?

Yes, prior experience in pharma, biotech, or regulatory consulting environments is preferred.

4. Does this role involve direct client communication?

Yes, the Document Specialist will interact with clients to ensure submission accuracy and timeline management.

5. Is remote work allowed?

Yes, ProPharma supports remote and hybrid working models depending on candidate location and team requirements.

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Summary

Company	ProPharma
Vacancies	Document Specialist
Required Education	B.Pharm, M.Pharm, PharmD, BSc Life Sciences, MSc Life Sciences, MSc Biotechnology, MSc Microbiology, MSc Clinical Research, Diploma/Certification in Regulatory Affairs
Experience	Minimum 3 Years in Regulatory Document Publishing & eCTD Submissions

Tagged as: Pharma Jobs in Bangalore