Associate Global Regulatory Manager, GRSS&C

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; In loco; INR 1.200.000 - 2.400.000; Tempo pieno

Descrizione del lavoro

IN10 (FCRS = IN010) Novartis Healthcare Private Limited in Hyderabad, India seeks an aGRM-RACS Regulatory professional to manage regulatory clinical trials and maintenance submissions under supervision, ensuring timely, compliant, scientifically accurate submissions.

You will collaborate with study teams and country/regional leaders, handle HA interactions, and contribute to process improvements and automation while applying regulatory expertise across major markets.

Competenze

• Science based BS or MS with requisite experience.
• Advanced degree (MD, Ph D, PharmD) preferred.
• Regulatory affairs experience of 7 to 10 years with knowledge of regulations for maintenance activities.
• Experience of regulatory submission and approval processes in major countries.

Mansioni

• Managing regulatory clinical trials or maintenance submissions under supervision.
• Collaborate with study teams and Country lead to ensure timely, compliant submissions.
• Identify issues and tradeoffs to avoid delays and achieve timely approvals.
• Respond to health authority queries and prepare strong justifications.

Conoscenze

Data Analysis

Regulatory Compliance

Waterfall Model

Formazione

BS/MS in science

Advanced degree preferred (MD/PhD/PharmD)

Descrizione del lavoro

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.

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

Company Culture

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.