Role & responsibilities (ROW markets, Mexico, and Canada)

Job Purpose To manage regulatory submissions, product registrations, and lifecycle activities across ROW markets, including Mexico and Canada, ensuring compliance with applicable regulatory requirements and timely achievement of registration and approval targets.

Key Responsibilities

- Prepare, compile, review, and submit CTD/eCTD dossiers for new product registrations across ROW markets, Mexico, and Canada.
- Manage regulatory activities, including current registrations, variations renewals, amendments, and post-approval submissions.
- Prepare and coordinate responses to health authority queries and deficiency letters in collaboration with cross-functional teams.
- Support Mexican regulatory submissions to COFEPRIS and Canadian submissions to Health Canada, including applicable NDS/ANDS and generic drug registration pathways.




- Assess country-specific regulatory requirements and monitor regulatory updates to ensure ongoing compliance.
- Coordinate with internal departments, CMOs, local agents, and regulatory consultants to obtain required technical and administrative documentation.
- Maintain regulatory trackers, submission timelines, approval records, and registration databases.
- Identify regulatory risks and ensure timely completion of submissions, renewals, and regulatory commitments.

Preferred candidate profile

- 7+ years of pharmaceutical Regulatory Affairs experience in the relevant international markets.
- Good knowledge of CTD dossier preparation, generic product registrations, and post-approval lifecycle management.
- Familiarity with COFEPRIS requirements for Mexico and Health Canada requirements for Canada.

📌 Assistant Manager - Regulatory Affairs (Vadodara)
🏢 Novumgen
📍 Vadodara