Associate Global Regulatory Manager GRSSandC

Novartis; Hyderabad; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Novartis in Hyderabad seeks an experienced regulatory professional to manage regulatory clinical trials and maintenance activities across regions. You will collaborate with study teams and country leads to ensure timely, compliant submissions and approvals, while maintaining country knowledge and regulatory lifecycle continuity.

The role emphasizes preparing robust justifications, entering product attributes accurately, and contributing to process improvement and automation within a global

Qualifications

• Science-based BS/MS; advanced degree preferred.
• 7–10 years regulatory affairs experience with maintenance exposure.
• Experience with regulatory submissions and approvals in major markets.
• Ability to drive process improvements and automation initiatives.
• Experience in global/matrix environments within pharma.

Responsibilities

• Ensure regulatory submissions are prepared on time and in compliance with regulations and Novartis processes.
• Manage assigned product portfolio and country/region knowledge.
• Use regulatory expertise to identify issues, gaps, and tradeoffs to avoid delays.
• Provide timely responses to health authority queries and prepare strong justifications.
• Enter product attributes in compliance databases and RIMs.
• Facilitate preparation of documents for health authority interactions for low complexity.
• Contribute to productivity, continuous improvement, and automation initiatives.
• Share knowledge and support other associates within Regulatory Affairs.

Skills

Data Analysis

Regulatory Compliance

Waterfall Model

Education

Science-based BS/MS

Advanced degree preferred (MD/PhD/PharmD)

Job description

Job Description:

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.
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

• 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

Skills Desired

Data Analysis, Regulatory Compliance, Waterfall Model