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 US Markets.
Key Responsibilities:
Regulatory Compliance:
Strong understanding of U.S. regulatory requirements, particularly FDA guidelines, and will be responsible for preparing and submitting regulatory documentation for ANDA, maintaining compliance records, and liaising with regulatory agencies. Knowledge about post approval activities is an added advantage.
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 and review artworks and comparative labeling texts. 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 and decision-making.
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
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