Regulatory Associate
18 hours ago
DDReg Pharma
DDReg Pharma
Full Time
Gurgaon
Posted 5 hours ago
**Job Purpose**:
**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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