Associate Global Regulatory Manager, GRSS&C

About the role

Novartis is hiring an Associate Global Regulatory Manager (GRSS&C) in Hyderabad. The role manages regulatory clinical trials or maintenance activities under supervision, focusing on regulatory submissions for clinical trial applications or the maintenance of the assigned portfolio for selected countries or regions. It works with the study team, the country lead and line functions to ensure complete, scientifically accurate and compliant submissions are reviewed and approved on time.

Key responsibilities

• Ensure clinical trial applications and maintenance submissions are prepared on time and in compliance with regulations, guidelines and Novartis processes
• Manage the assigned product portfolio and country/region knowledge
• Identify issues, gaps and trade-offs to avoid delays and achieve timely submission and approval
• Handle regulatory authority (HA) queries and prepare strong justifications for regulatory gaps
• Enter product-specific attributes in the compliance database and applicable RIMs
• Facilitate preparation of documents for low-complexity HA interactions
• Contribute to productivity, continuous improvement and automation initiatives, and share knowledge with other associates

Required profile

• Science-based BS or MS with demonstrated capability; advanced degree (MD, PhD, PharmD) preferred
• 7 to 10 years of regulatory affairs experience (at least 5 years relevant), covering regulations, guidelines and maintenance activities
• Experience of regulatory submission and approval processes in major countries
• Planning, execution, reporting, regulatory review, compliance and submission experience
• Understanding of safety and efficacy data and product labels
• Experience in a global or matrix environment or cross-functional teams in the pharmaceutical industry

Required skills

• Data analysis
• Regulatory compliance
• Waterfall model