Associate- Drug Regulatory Affairs_Canada_ (2+yrs Exp)

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
  

Related Blog Post
Associate- Drug Regulatory Affairs_US_ (2+yrs Exp)
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 US Markets. Key Responsibilities: Regulatory Compliance:Strong understanding of U.S. regulatory…October 28, 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, 2025Senior Manager-Regulatory Affairs-EU/USSr. 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, 2025