Regulatory Affairs Associate

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 assigned territories. 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