Novartis

Actively Hiring

Regulatory Affairs Clinical Manager

Hyderabad, India

Full time

Role Overview

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.

About Novartis

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.

Key Responsibilities

Ensures under supervision that clinical trial applications or maintenance submissions are prepared on time and in compliance with regulatory regulations
Manage assigned product portfolio and country / region knowledge
Manage timely responses to HA queries and collaborate with regulatory lead to preparing strong justifications
Responsible for appropriate entering of product specific attributes in compliance database and applicable RIMs
Contribute to non-project related initiatives focused on productivity, continuous improvement, and automation

Requirements & Eligibility

Science based BS or MS with requisite experience and demonstrated capability
Regulatory affairs experience of 7 to 10 years with knowledge of regulations, guidelines and regulatory processes for maintenance activities
Experience of regulatory submission and approval processes in major countries
Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry

Required Skills & Tech

Data AnalysisRegulatory ComplianceWaterfall ModelRegulatory Affairs