Regulatory Affairs Associate

2 days ago

Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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 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

Soft Skills:


•Strong communication and interpersonal skills


•Time management and multitasking


•Analytical thinking and collaboration


•Positive, adaptable attitude

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