Global Regulatory Manager GRSSandC

Novartis India; India; Sur place; INR 1 800 000 - 2 800 000; Plein temps

Résumé du poste

Novartis India is seeking a Global Regulatory Manager - Regulatory Affairs for Regulatory Clinical Trials Submissions (GRM-RACS). The role independently manages regulatory clinical trials or maintenance activities across assigned countries, ensuring timely, compliant submissions.

The GRM-RACS collaborates with study teams and country leads to deliver high-quality, scientifically accurate submissions and to address regulatory gaps efficiently.

Qualifications

• Science-based BS or MS with experience; advanced degree preferred.
• Regulatory affairs experience 9 to 13 years (at least 7 years relevant) with knowledge of maintenance processes.
• Experience with regulatory submission and approval processes in major countries.
• Ability to participate in process improvements, simplification, automatization and operational excellence initiatives.
• Understand safety and efficacy data and product labels; strong communication in a global team.

Responsabilités

• For a product portfolio, ensure regulatory submissions are prepared on time and in compliance.
• Manage assigned product portfolio and country/region knowledge.
• Use regulatory expertise to identify issues and minimize delays and ensure timely submissions.
• Respond to HA queries and prepare strong justifications addressing regulatory gaps.
• Enter product attributes in compliance database and RIMs.
• Prepare documents for HA interactions for low-complexity matters.
• Contribute to productivity, continuous improvement, and automation initiatives.
• Share knowledge and support other Regulatory Affairs associates.

Connaissances

Regulatory submissions

Regulatory maintenance

Cross-functional collaboration

Process improvements

Communication

Formation

Science BS/MS

Advanced degree preferred (MD/PhD/PharmD)

Description du poste

Job Description:

Summary

Responsible for managing regulatory clinical trials or maintenance activities independently. The GRM focuses on the delivery of regulatory activities related to clinical trial applications or to the maintenance of the assigned portfolio for selected countries/region.

The GRM-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.

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

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
• Regulatory affairs experience of 9 to 13 (at least 7 years of relevant exp) with knowledge of regulations, guidelines and regulatory processes for maintenance activities
• Experience of regulatory submission and approval processes in major countries. Planning, execution, reporting, regulatory review, compliance and submission experience
• Ability to 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
• Basic organizational awareness (e.g., interrelationship of departments). Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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