Associate Global Regulatory Manager, GRSS&C

Novartis India; Hyderabad; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Novartis India seeks a regulatory affairs professional to manage clinical trial applications and maintenance submissions under supervision. You will ensure timely, compliant filings and maintain knowledge across portfolios and regions.

You will collaborate with study teams and country leads to address regulatory gaps, respond to HA queries, and contribute to productivity and automation initiatives in a global matrix setting.

Qualifications

• Regulatory affairs experience in pharmaceutical industry.
• Experience with regulatory submissions and approvals in major regions.
• Ability to participate in process improvements and cross-functional collaboration.

Responsibilities

• For a product portfolio, ensure regulatory submissions are prepared on time and compliant.
• Manage assigned product portfolio and country/region knowledge.
• Identify issues and gaps to prevent delays and secure timely submissions.
• Respond to health authority queries and prepare strong justifications.
• Enter product attributes in compliance databases and RIMs.
• Prepare documents for HA interactions for low-complexity matters.
• Contribute to productivity, automation, and continuous improvement initiatives.
• Share knowledge and support colleagues in Regulatory Affairs.

Skills

Regulatory affairs

Clinical trials

Documentation

Regulatory submissions

Cross-functional teams

Education

Science BS/MS

Advanced degree preferred (MD/PhD/PharmD)

Job description

Summary

Responsible for managing regulatory clinical trials or maintenance activities under supervision, the aGRM-RACS focuses on the delivery of regulatory activities related to clinical trial applications or to the maintenance of the assigned portfolio for selected countries/region.

Summary

Responsible for managing regulatory clinical trials or maintenance activities under supervision, the aGRM-RACS 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 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.

About The Role

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 7 to 10 (at least 5 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

Benefits and Rewards

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