Full-Time
Salary: 25k to 30k
Positions: 10

Pharmacovigilance Services Associate

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Job Description

Company: DDReg Pharma
Job Type: Full Time
Location: Gurgaon
Posted: 18 hours ago

Introduction

 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 and eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.

Role & Responsibilities

  • Compliance and lifecycle management include preparation of variation and requalification dossiers and managing regulatory product maintenance across EU, UK, WHO, and other emerging markets.

  • eCTD and CTD sequence review involves performing Level-1 review of sequences for DKT, FHI, and BO product submissions to ensure submission quality and regulatory compliance. 
  • Functional file preparation includes handling electronic publishing tasks such as hyperlinking, bookmarking, redactions, and formatting with technical accuracy to minimize rework.
  • Query handling and documentation include drafting and reviewing responses to regulatory authorities, ensuring clarity, regulatory alignment, and timely submission.
  • Artwork and labeling review ensures annotated artwork and comparative labeling texts are accurate, consistent, and compliant with regulatory standards.

  • Project tracking and documentation involve maintaining trackers, task planners, product history logs, and query records to ensure timely and accurate reporting for internal and client use.

  • Team collaboration and communication promote smooth interaction with internal teams and external clients, ensuring documentation clarity and professional coordination.

Educational Qualification

  •  B.Pharm or M.Pharm

Location

Gurgaon

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