Associate- Regulatory Affairs

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
  

Related Blog Post
Senior Manager-Regulatory Affairs-EU/US
Sr. Manager-Regulatory Affairs- US/EU Experience: -15+ YearsLocation: Gurgaon We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory…September 29, 2025Assistant Manager – Regulatory Affairs – EUJob Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation,…October 7, 2025Project Manager – Regulatory AffairsJob Summary: We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks,…September 23, 2025