Novartis

Actively Hiring

Regulatory Affairs Manager

Hyderabad, India

Full time

Role Overview

Responsible for managing regulatory clinical trials or maintenance activities independently, focusing 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

Novartis is a focused global medicines company reimagining medicine to improve and extend people's lives using innovative science and digital technologies.

Key Responsibilities

Ensure 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 prepare strong justifications
Enter product specific attributes in compliance database and applicable RIMs
Facilitate preparation and finalization of documents for HA interactions
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
Advanced degree (MD, Ph D, PharmD) preferred
Regulatory affairs experience of 9 to 13 years with at least 7 years of relevant experience
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