Full Time
Gurgaon
Posted 2 days 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