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DDReg Pharma Pvt. Ltd.
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Regulatory Associate

Regulatory Associate

DDReg Pharma Pvt. Ltd.

6 years

0 Lacs

gurgaon haryana india

Posted:1 day ago| Platform:

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Skills Required

support management documentation compliance maintenance sequence query publishing formatting labeling consistency tracking collaboration communication initiation authorization analysis remediation development strategies gcc controls

Work Mode

On-site

Job Type

Full Time

Job Description

Job Purpose

We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.

Key Responsibilities

Compliance & Lifecycle Management: Prepare variation and requalification dossiers. Manage regulatory product maintenance across EU, UK, WHO, and other emerging markets.
eCTD/CTD Sequence Review: Perform Level-1 review of CTD/eCTD sequences for DKT, FHI, and BO product submissions. Ensure submission quality and compliance with productivity and regulatory standards.
Query Handling & Documentation: Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission.
Functional File Preparation: Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework.
Artwork & Labeling Review: Review annotated artwork and comparative labeling texts. Ensure accuracy, consistency, and regulatory compliance.
Project Tracking & Documentation: Maintain trackers, task planners, product history logs, and query records. Ensure accurate and timely updates for internal and client reporting.
Team Collaboration & Communication: Facilitate smooth communication with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.

Educational Qualifications

B Pharm/ M Pharm

Soft Skills

Strong communication and interpersonal skills
Time management and multitasking
Analytical thinking and collaboration
Positive, adaptable attitude

Related
Assistant Manager – Regulatory Affairs – EU
Job Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation,…May 22, 2025Similar postProject Manager – Regulatory AffairsJob Summary: We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks,…August 12, 2025Similar postManager – Regulatory Affairs – EMJob Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN. Review of CTD dossiers , variations, change controls, renewals…May 22, 2025Similar post

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Regulatory Associate