Associate- Drug Regulatory Affairs_ GHC/KSA_

2 days ago


Gurgaon, Haryana, India e6f468b3-f068-4078-b55c-52e84010ae1f Full time ₹ 6,00,000 - ₹ 18,00,000 per year

DDReg Pharma

DDReg Pharma

Full Time

Gurgaon

Posted 11 hours ago

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 GHC/KSA.

Key Responsibilities:

Compliance & Lifecycle Management: Prepare variation and requalification dossiers. Manage regulatory product maintenance across GHC/KSA.

eCTD/CTD Sequence Review: Perform Level-1 review of CTD/eCTD sequences for assigned territories. 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

Why Join Us

Opportunity to contribute to key regulatory submissions

Exposure to global health authority expectations

Skill development and continuous learning environment

Collaborative work culture

Related Blog Post

Job Features

Job Category

Regulatory Affairs



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