Global Regulatory Manager - Clinical Trials and Regulatory Submissions

Novartis India; Hyderabad; Presencial; INR 1.800.000 - 3.200.000; Jornada completa

Descripción de la vacante

Novartis India seeks a Global Regulatory Manager for GRSS&C to independently manage regulatory clinical trials and maintenance for assigned portfolios. The role focuses on timely, compliant submissions and collaboration with study teams and country leads in a global matrix environment.

Qualifications include a science-based BS or MS with 9–13 years in regulatory affairs and 7+ years in relevant roles; MD/PhD/PharmD preferred. Prior experience with major country submissions is required.

Formación

• Science-based BS or MS with requisite experience.
• Advanced degree (MD, Ph D, PharmD) preferred.
• Regulatory affairs experience of 9 to 13 years (at least 7 years relevant).
• Experience of regulatory submission and approval processes in major countries.
• Experience in a global/matrix environment or cross-functional teams.

Responsabilidades

• For a product portfolio, ensure regulatory submissions are prepared on time and in compliance with regulations and Novartis processes.
• Manage assigned product portfolio and country/region knowledge.
• Identify issues, gaps, and tradeoffs to avoid delays and achieve timely submissions and approvals.
• Respond to HA queries and prepare strong justifications to address regulatory gaps.
• Enter product attributes in compliance database and applicable RIMs.
• Prepare and finalize documents for HA interactions for low complexity matters.
• Contribute to productivity, continuous improvement and automation initiatives.
• Share knowledge and support other associates within Regulatory Affairs.

Conocimientos

Data Analysis

Regulatory Compliance

Waterfall Model

Educación

BS or MS in science

MD/PhD/PharmD preferred

Descripción del empleo

Global Regulatory Manager, GRSS&C 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.

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 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.

Skills Desired

• Data Analysis, Regulatory Compliance, Waterfall Model

Experience Level Mid Level