Associate- Regulatory Affairs

2 days ago


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

DDReg Pharma

DDReg Pharma

Full Time

Gurgaon

Posted 14 minutes 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 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

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Job Category

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