Regulatory Publishing Specialist job at DDReg Pharma

Regulatory Publishing Specialist job: Are you an experienced Regulatory Affairs or Regulatory Operations professional looking for an opportunity in regulatory publishing? DDReg Pharma is hiring a Regulatory Publishing Specialist to support global regulatory submissions and ensure that electronic submissions meet the required quality and compliance standards.

This role is suitable for professionals with 3–8 years of relevant experience in regulatory operations or regulatory publishing and hands-on experience with eCTD publishing, submission lifecycle management, and regulatory publishing tools such as DocuBridge and Lorenz.

Regulatory Publishing Specialist job Overview

About the Role

The Regulatory Publishing Specialist will be responsible for the preparation, compilation, publishing, validation, submission, archiving, and lifecycle management of global regulatory submissions.

The professional will work with eCTD publishing and validation tools, including DocuBridge, Lorenz, and eValidator, and will support submissions intended for regulatory agencies such as the FDA and EMA.

The role requires excellent attention to detail, technical knowledge of regulatory publishing standards, troubleshooting abilities, and effective coordination with cross-functional teams.

Key Responsibilities

1. Regulatory Submission Publishing

The selected candidate will:

• Publish initial applications, supplements, variations, annual reports, renewals, responses, and lifecycle maintenance submissions.
• Use DocuBridge, Lorenz, or equivalent regulatory publishing tools.
• Compile and assemble regulatory submission packages according to global and regional requirements.
• Ensure accurate and timely electronic submission delivery.
• Manage the lifecycle of eCTD submissions, including sequences, replacements, amendments, and withdrawals.
• Verify that submission components are complete and correctly placed before dispatch.

2. eCTD Compliance and Quality Control

Responsibilities include:

• Ensuring submissions comply with FDA, EMA, ICH, and regional eCTD standards.
• Performing technical validation and quality-control checks.
• Reviewing submission structure, metadata, hyperlinks, bookmarks, file formats, naming conventions, and document placement.
• Identifying and correcting technical validation errors.
• Maintaining submission accuracy, consistency, and technical quality.

3. Submission Planning and Coordination

The Regulatory Publishing Specialist will coordinate with teams such as:

• Regulatory Affairs
• Medical Writing
• CMC
• Quality
• Clinical
• Pharmacovigilance

The candidate will also:

• Participate in submission planning meetings.
• Track submission timelines, deliverables, dependencies, and risks.
• Follow up with stakeholders for required documents and information.
• Identify possible submission delays and recommend mitigation strategies.

4. Technical Issue Resolution

The role also involves:

• Troubleshooting publishing and validation issues.
• Resolving document-formatting and submission-related technical problems.
• Working with internal teams, vendors, external partners, and regulatory stakeholders.
• Providing operational support during critical submission periods.
• Escalating major technical or compliance issues when required.
• Supporting regulatory publishing systems and tools.

5. Subject Matter Expertise and Training

The selected professional may also work as a Subject Matter Expert (SME) for:

• eCTD publishing
• Regulatory publishing tools
• Submission standards
• Publishing best practices

Other responsibilities include:

• Providing technical guidance to internal teams.
• Conducting training sessions.
• Preparing training materials and user guides.
• Maintaining SOPs, work instructions, checklists, and related documents.
• Staying updated with changes in global regulatory submission requirements.

6. Documentation and Archive Management

The candidate will be responsible for:

• Maintaining complete and organized electronic submission archives.
• Managing version control and lifecycle documentation.
• Maintaining submission records in Document Management Systems (DMS) or Regulatory Information Management (RIM) systems.
• Supporting audit readiness and regulatory inspection preparedness.
• Maintaining documents according to applicable retention requirements.

7. Process Improvement

The role includes opportunities to contribute to continuous improvement by:

• Creating and maintaining process maps.
• Identifying opportunities for standardization and automation.
• Developing publishing templates and quality-control mechanisms.
• Improving version-management practices.
• Supporting initiatives designed to improve submission quality, efficiency, and compliance.

Eligibility and Qualifications

Candidates should have:

• A Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Biological Sciences, or a related discipline.
• Postgraduate qualification or certification in Regulatory Affairs will be preferred.
• 3–8 years of relevant experience in Regulatory Operations or Regulatory Publishing.
• Hands-on experience with DocuBridge, Lorenz, eValidator, or equivalent tools.
• Experience preparing and publishing FDA, EMA, and other global eCTD submissions.
• Experience handling lifecycle submissions such as variations, supplements, annual reports, renewals, and regulatory responses.
• Experience with Document Management Systems or Regulatory Information Management systems will be an advantage.

Technical Skills Required

Candidates should have knowledge or experience in:

• eCTD publishing
• eCTD submission lifecycle management
• FDA and EMA submission requirements
• ICH electronic submission standards
• DocuBridge
• Lorenz
• eValidator or equivalent validation tools
• PDF preparation
• Hyperlinking
• Bookmarking
• Metadata
• Document formatting
• Microsoft Office
• Document Management Systems
• Regulatory Information Management systems

Key Competencies

The ideal candidate should have:

• Strong attention to detail.
• Good analytical and troubleshooting skills.
• Strong regulatory submission-planning abilities.
• Excellent communication and stakeholder-management skills.
• Ability to manage multiple submissions simultaneously.
• Good time-management skills.
• Ability to work under strict submission deadlines.
• Ability to work independently and within cross-functional teams.
• A continuous-learning and process-improvement mindset.

Who Can Apply?

This opportunity is particularly relevant for professionals working in:

• Regulatory Affairs
• Regulatory Operations
• Regulatory Publishing
• eCTD Publishing
• Regulatory Submission Management

Candidates with experience in global regulatory submissions and eCTD publishing tools may be particularly suitable for this position.

How to Apply for DDReg Pharma Regulatory Publishing Specialist?

Interested and eligible candidates can apply by submitting their updated CV through the application process.

Email: [email protected]

Company: DDReg Pharma

Frequently Asked Questions (FAQs)

1. What is the job role at DDReg Pharma?

DDReg Pharma is hiring for the position of Regulatory Publishing Specialist – Regulatory Affairs.

2. What is the required experience?

The required experience is 3–8 years in Regulatory Operations or Regulatory Publishing.

3. What qualification is required?

A Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Biological Sciences, or a related discipline is required. A postgraduate qualification or certification in Regulatory Affairs is preferred.

4. Which regulatory publishing tools are required?

Experience with DocuBridge, Lorenz, eValidator, or equivalent regulatory publishing and validation tools is required.

5. What is eCTD?

eCTD (electronic Common Technical Document) is a standardized electronic format used to organize and submit regulatory information to health authorities.

6. Which regulatory agencies are relevant to this role?

The role involves supporting submissions according to requirements of agencies and standards including FDA, EMA, ICH, and other regional regulatory authorities.

7. Is this role suitable for freshers?

No. The job description specifically requires 3–8 years of relevant experience in Regulatory Operations or Regulatory Publishing.

8. How can eligible candidates apply?

Candidates can submit their updated CV through the application process or contact [email protected].

Editorial Note

This article has been carefully researched and written by Deepak Rajput with a focus on accuracy, clarity, and evidence-based healthcare information. Pharmaacademias.com