Associate – Drug Regulatory Affairs (US & Canada) | DDReg Pharma

DDReg Pharma, a global regulatory consulting company, is hiring Associates in Drug Regulatory Affairs for US and Canada markets at its Gurgaon office. This opportunity is perfect for pharmaceutical professionals with over 2 years of experience in regulatory submissions, CTD/eCTD documentation, and global compliance.

If you’re looking to enhance your expertise in Regulatory Affairs with exposure to Health Canada and US FDA submissions, this is the ideal role for you.

🧾 Key Responsibilities

For Canada Market:

• Prepare and submit regulatory documentation for ANDS in compliance with Health Canada regulations.
• Maintain up-to-date knowledge of CTD/eCTD requirements.
• Review submission sequences for accuracy and compliance.
• Draft responses to regulatory authority queries.
• Handle electronic publishing tasks including hyperlinking, bookmarking, and formatting.
• Prepare and review label texts and artworks ensuring regulatory accuracy.
• Track project documentation, client communications, and timelines effectively.

For US Market:

• Prepare and submit regulatory documentation for ANDA applications in accordance with FDA guidelines.
• Manage post-approval regulatory activities as needed.
• Review eCTD sequences and ensure submission quality.
• Prepare and review comparative labeling and artwork.
• Maintain product history logs, task planners, and regulatory trackers.
• Collaborate with cross-functional teams and external clients for timely deliverables.

🎓 Educational Qualifications

• B.Pharm / M.Pharm from a recognized institution.

💼 Required Skills & Competencies

• Strong understanding of Health Canada and US FDA regulatory frameworks.
• Hands-on experience with CTD/eCTD documentation and submission tools.
• Excellent communication and analytical skills.
• Strong time management and ability to multitask.
• Proactive, adaptable, and detail-oriented approach.

💰 Compensation & Benefits

• Salary Range: ₹5,00,000 – ₹8,00,000 per annum (based on experience).
• Performance-linked incentives.
• Opportunity for professional growth in global regulatory projects.
• Collaborative and learning-driven work environment.

🕒 Job Details

• Position: Associate – Drug Regulatory Affairs (US / Canada)
• Company: DDReg Pharma
• Location: Gurgaon, India
• Experience: 2+ years
• Employment Type: Full-time
• Posted Date: October 28, 2025
• Valid Through: November 27, 2025

📩 How to Apply

Application Link for For Canada Market

Application Link for For US Market