Assistant Manager - Regulatory Affairs

Novumgen; Vadodara; On-site; INR 1,200,000 - 2,300,000; Full time

Job summary

Novumgen Limited is seeking an experienced Regulatory Affairs professional to manage regulatory submissions across ROW markets, including Mexico and Canada. You will oversee CTD/eCTD dossiers, lifecycle management, and cross-functional coordination with COFEPRIS and Health Canada teams.

The role requires 7+ years in international regulatory affairs, strong CTD know-how, and proficiency in coordinating with CMOs and regulatory consultants to ensure timely approvals.

Qualifications

• 7+ years in pharmaceutical regulatory affairs across international markets.
• Strong knowledge of CTD dossier preparation, generic registrations, and lifecycle management.
• Familiarity with COFEPRIS (Mexico) and Health Canada (Canada) requirements.

Responsibilities

• Prepare, review, and submit CTD/eCTD dossiers for new registrations in ROW markets including Mexico and Canada.
• Manage regulatory activities: new registrations, variations, renewals, amendments, and post-approval submissions.
• Coordinate responses to health authority queries with cross-functional teams.
• Support COFEPRIS and Health Canada submissions, including NDS/ANDS and generic pathways.
• Assess country-specific regulatory requirements and monitor updates for compliance.
• Coordinate with CMOs, local agents, and consultants to obtain required documentation.
• Maintain regulatory trackers, timelines, and registration databases.
• Identify regulatory risks and ensure timely completions of submissions and commitments.

Skills

Regulatory affairs

CTD/eCTD prep

Cross-functional collab

Lifecycle management

Job description

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 new 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.