We are looking for a seasoned regulatory leader to head our Canada regulatory portfolio! If you have solid expertise in Health Canada submissions and lifecycle management, wed love to connect with you.

Role Details

Position: Assistant General Manager (AGM) - Regulatory Affairs

Market Focus: Canada (Health Canada / TPD)

Location: Mumbai (On-site / Hybrid as applicable)

Experience: 10 – 15 years in Pharma Regulatory Affairs (specifically Canadian generic/innovator formulations)

Qualification: B.Pharm / M.Pharm / M.Sc.

Key Responsibilities

Lead end-to-end regulatory strategy and dossier preparation for ANDS, NDS, and Supplements in eCTD format.

Manage high-stakes Health Canada interactions, including responses to Clarifax, NOD (Notice of Deficiency), and NON (Notice of Non-Compliance).

Oversee CMC documentation, Canadian Product Monograph (PM)



alignments, and bioequivalence study compliance.

Navigate Post-NOC changes (Level I, II, III) and lifecycle management activities.

Mentor the regulatory team and partner with cross-functional R&D;, ARD, and Manufacturing units.

Ideal Candidate Profile

10+ years of hands-on experience handling Health Canada submissions and regulatory filings.

Deep knowledge of the Food and Drugs Act & Regulations, Post-NOC guidelines, and eCTD Module 1 (Canadian DTD).

Proven track record of independently managing regulatory projects, agency queries, and stakeholder deliverables.

Based in Mumbai or willing to relocate.

📌 Assistant General Manager-RA (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai