Associate Global Regulatory Manager, GRSS&C

Job Description Summary

The aGRM-RACS collaborates with the study team or with the Country lead and the line functions to ensures high quality (complete, well organized, scientifically accurate, compliant) submissions are prepared, reviewed and timely approved.

Job Description

Key Responsibilities:

• For a product portfolio, the aGRM- RACS ensures under supervision that clinical trial applications or maintenance submissions are prepared on time and in compliance with regulatory regulations, guidelines, and in line with Novartis processes and system requirements.
• Manage assigned product portfolio and country / region knowledge.
• Use regulatory expertise and knowledge to identify issues, gaps, and tradeoffs to avoid/minimize delays and achieve timely submission and approvals.
• Manage timely responses to HA queries and collaborate with regulatory lead to preparing strong justifications to address regulatory gaps.
• Responsible for appropriate entering of product specific attributes in compliance database and applicable RIMs.
• Facilitate preparation and finalization of documents for HA interactions for matters of low complexity.
• Contribute to non-project related initiatives focused on productivity, continuous improvement, and automation.
• Share knowledge on specific topics and support other associates within Regulatory Affairs.

Minimum Requirement

• Sciencebased BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
• Regulatoryaffairs experience of 7 to 10 (at least 5 years of relevant exp) with knowledge of regulations, guidelines and regulatory processes for maintenance activities
• Experienceof regulatory submission and approval processes in major countries.Planning, execution, reporting, regulatory review, compliance and submission experience
• Abilityto participate in process improvements, simplification, automatization and operational excellence initiatives
• Understand safety and efficacy data and product labels. Reliable, timely, accurate and proactive communication as appropriate
• Basicorganizational awareness (e.g., interrelationship of departments). Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry

Skills Desired