Full Time
Gurgaon
Posted 15 hours 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 Canada Markets.
Key Responsibilities:
- Regulatory Compliance:
In-depth knowledge of Health Canada regulations, guidance documents, and submission formats. and will be responsible for preparing and submitting regulatory documentation for ANDS, maintaining compliance records, and liaising with regulatory agencies. - eCTD/CTD Sequence Review:
Maintain up-to-date knowledge of eCTD requirements and review of the sequence to ensure submission quality and compliance with 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:
Prepare label texts and review of artworks. Ensure accuracy, consistency, and regulatory compliance. - Project Tracking & Documentation:
Maintain trackers, task planners, product history logs, and query records. Participate in client meetings and contribute to regulatory planning. - Team Collaboration & Communication:
Collaborate 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