Global Regulatory Manager, GRSS&C

About the role

Novartis is looking for a Global Regulatory Manager (GRSS&C) in Hyderabad. The role manages regulatory clinical trials or maintenance activities independently, focusing on regulatory submissions for clinical trial applications or on maintaining the assigned portfolio for selected countries or regions. The manager works with the study team, the country lead and line functions so that submissions are complete, scientifically accurate, compliant and approved on time.

Key responsibilities

• Prepare clinical trial applications and maintenance submissions on time and in compliance with regulations, guidelines and Novartis processes and systems
• Manage the assigned product portfolio and country/region knowledge
• Identify issues, gaps and trade-offs to avoid delays and achieve timely submission and approvals
• 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 interactions with regulatory authorities
• Contribute to productivity, continuous improvement and automation initiatives, and share knowledge with colleagues in Regulatory Affairs

Required profile

• Science-based BS or MS with the required experience; advanced degree (MD, PhD, PharmD) preferred
• 9 to 13 years of regulatory affairs experience (at least 7 years relevant), covering regulations, guidelines and maintenance activities
• Experience of regulatory submission and approval processes in major countries, including planning, execution, reporting, review, compliance and submission
• 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