Pharmaceutical Regulatory Documentation Specialist

Why This Role Matters

In the pharmaceutical industry, regulatory approval is the gateway to market access. Without a well-prepared, technically accurate, and guideline-compliant dossier, even the most effective formulation cannot reach patients. The Regulatory Affairs Executive plays a central role in compiling and reviewing regulatory submissions in alignment with international standards such as the Common Technical Document (CTD) and ASEAN Common Technical Dossier (ACTD) formats.
This role directly supports global product registrations across ROW (Rest of World), LATAM, and African markets. Each region has unique regulatory expectations, documentation standards, and technical review procedures. A well-prepared dossier ensures faster approvals, reduced queries, and successful product launches.
By preparing high-quality technical documents, validating analytical data in line with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, and responding to regulatory authority queries, this position contributes significantly to the company’s international expansion and regulatory credibility.

Job Description

The Regulatory Affairs Executive is responsible for preparation, compilation, review, and submission of pharmaceutical dossiers as per CTD/ACTD formats and country-specific requirements. The role involves coordination with manufacturing, quality assurance, analytical development, and R&D teams to gather technical data for regulatory submissions.
The candidate will handle documentation for multiple dosage forms including oral solids, liquids, injectables, ophthalmic, and topical formulations. Additionally, this role involves responding to regulatory authority queries, reviewing Drug Master Files (DMFs), and supporting product development documentation aligned with global regulatory standards.
The position requires strong technical writing skills, attention to detail, regulatory knowledge, and the ability to manage multiple submissions simultaneously.

Key Features of the Role

• Preparation of CTD and ACTD dossiers for global markets
• Exposure to ROW, LATAM, and African regulatory frameworks
• Handling diverse dosage forms
• Interaction with cross-functional technical teams
• Direct involvement in regulatory query management

Responsibilities

• Prepare and compile dossiers in CTD and ACTD formats (Modules I, II, III, IV, and V) as per country-specific regulatory requirements.
• Draft and review technical documents including raw material specifications and finished product specifications.
• Document manufacturing processes and product development reports.
• Compile and review stability study reports and process validation documents.
• Review analytical method validation documents in compliance with ICH guidelines.
• Conduct Drug Master File (DMF) review to ensure completeness and regulatory compliance.
• Prepare and submit Product Dossiers (PD) for product registration in international markets.
• Respond to technical queries raised by regulatory authorities.
• Coordinate with Quality Assurance, R&D, Production, and Analytical teams for data collection.
• Ensure accuracy, consistency, and completeness of regulatory submissions.
• Maintain regulatory documentation archives and version control systems.
• Monitor updates in global regulatory requirements and adapt documentation accordingly.

Dosage Forms Handled

• Oral Solid Dosage Forms (Tablets, Capsules)
• Liquid Formulations
• Injectable Products
• Ophthalmic Preparations
• Topical Dosage Forms

Market Exposure

• ROW (Rest of World) Markets
• Latin American (LATAM) Countries
• African Regulatory Markets

Required Qualifications

• Bachelor’s degree in Pharmacy (B.Pharm) or Master’s degree in Pharmacy (M.Pharm).
• 1–5 years of experience in pharmaceutical regulatory affairs or dossier preparation.
• Strong understanding of CTD and ACTD formats.
• Knowledge of ICH guidelines for analytical validation and stability studies.

Educational Requirements

• B.Pharm / M.Pharm (Regulatory Affairs, Pharmaceutics, Pharmaceutical Analysis preferred).
• Additional training in international regulatory documentation is advantageous.

Experience and Skills

• Hands-on experience in dossier preparation for international markets.
• Strong knowledge of CTD Modules I–V.
• Familiarity with ACTD requirements for ASEAN and other regions.
• Experience reviewing analytical method validation reports.
• Understanding of stability study requirements and process validation documentation.
• Ability to draft high-quality technical responses to regulatory authority queries.
• Strong documentation and technical writing skills.
• Excellent coordination skills for cross-functional collaboration.
• Ability to handle multiple submissions with strict deadlines.
• High level of accuracy and attention to detail.

Salary Insights

The offered salary range of ₹18,000 to ₹60,000 per month depends on:
• Years of regulatory experience
• Exposure to global markets (LATAM, Africa, ROW)
• Technical expertise in CTD/ACTD preparation
• Experience handling regulatory queries independently

In addition to base salary, the company provides Provident Fund benefits as per statutory requirements.

Company Overview

The organization operates within the pharmaceutical manufacturing and export sector, focusing on regulatory-compliant product registration across international markets. With a growing footprint in LATAM, African, and ROW markets, the company emphasizes technical excellence and adherence to global regulatory standards.
The regulatory affairs team plays a crucial role in ensuring that all submissions meet international guidelines and local regulatory authority expectations. Through accurate documentation and efficient query resolution, the team supports timely product approvals and global business expansion.

FAQs

1. What formats will the candidate work with?
   CTD and ACTD formats covering Modules I to V.

2. Is experience in multiple dosage forms required?
   Yes, experience handling oral, liquid, injectable, ophthalmic, and topical dosage forms is preferred.

3. Does the role involve query response handling?
   Yes, preparing and submitting technical responses to regulatory authorities is a key responsibility.

4. Which markets will be handled?
   ROW, LATAM, and African countries.

5. Is ICH knowledge mandatory?
   Yes, knowledge of ICH guidelines for method validation and stability studies is essential.

Application Tips

• Highlight direct experience with CTD/ACTD dossier preparation.
• Mention specific markets handled (LATAM, Africa, ROW).
• Provide examples of technical query responses you have prepared.
• Emphasize experience with stability data and process validation documentation.
• Showcase strong documentation and regulatory coordination skills.