Job Description: Assistant Manager – Regulatory Affairs (RA)
Job ID
REQ-10077465
Date Posted
12 May 2026
Location
Mumbai, India (Head Office)
Company
Novartis Healthcare Private Limited (IN10)
Division / Business Unit
Development / Development
Functional Area
Research & Development
Job Type
Full-time (Regular)
Shift
No
Role Summary
The Assistant Manager – Regulatory Affairs (RA) is responsible for managing controlled regulatory documentation, dossier submissions, and compliance activities in alignment with regulatory authority requirements.
The role ensures accurate documentation systems, regulatory submissions, lifecycle management, and ongoing compliance across products and markets.
Key Responsibilities
1. Regulatory Documentation & Records Management
Maintain controlled documentation systems and electronic records retention
Ensure compliance with regulatory authority requirements
Manage document classification, retention, and change control systems
Enforce formatting standards, SOPs, and regulatory documentation policies
2. Regulatory Submissions & Dossier Management
Lead compilation and submission of regulatory dossiers for:
New drug applications
Line extensions
Additional indications
Lifecycle changes (renewals, site registrations, production transfers)
Support CTA (Clinical Trial Application) submissions and lifecycle compliance
3. Regulatory Strategy & Lifecycle Support
Support regulatory strategy development for pipeline products
Enable timely market access through regulatory planning
Manage post-approval regulatory commitments including:
PSURs
CMC variations
Labeling updates
4. Compliance Monitoring & Tracking
Track regulatory submissions, approvals, and commitments
Ensure ongoing compliance with Health Authority requirements
Maintain regulatory databases and ensure data integrity
5. Cross-Functional Collaboration
Work with Legal, QA, Supply Chain, and Global teams
Support regulatory changes including:
Site changes
Legal entity updates
Supply chain adjustments
Ensure minimal business disruption during regulatory transitions
6. Regulatory Intelligence & Reporting
Monitor evolving regulatory requirements
Provide insights and guidance on regulatory changes
Prepare summaries, abstracts, and evaluation reports
7. Process Improvement & Quality Systems
Drive CAPA implementation and process improvements
Ensure audit readiness and inspection preparedness
Strengthen regulatory operational efficiency
Minimum Requirements
Education
Bachelor’s degree in:
Pharmacy
Life Sciences
Health Sciences
Chemistry
Experience
5+ years in Regulatory Affairs
Experience in Indian regulatory environment preferred
Hands-on experience in:
Dossier compilation
Regulatory submissions (NDA, CTA)
Lifecycle management
Core Knowledge
Understanding of:
CDSCO regulations
Clinical trial regulations in India
Post-approval compliance processes
Skills
Strong regulatory documentation and submission skills
Cross-functional collaboration and stakeholder management
Strong written and verbal communication
Attention to detail and compliance mindset
Desirable Requirements
Postgraduate degree in relevant scientific field
Exposure to global regulatory environments
Experience in regulatory strategy and product launches
Work Environment
Based in Mumbai, India
Part of global Development organization
Works with cross-functional regulatory and operational teams
Focus on compliance, submissions, and lifecycle management
Company Overview
Novartis is a global healthcare leader focused on improving patient outcomes through innovative medicines, strong regulatory compliance, and global collaboration.
Benefits & Culture
Strong regulatory career development path
Exposure to global submission processes
Structured compliance and quality systems
Inclusive and collaborative work environment
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