Global Regulatory Manager, GRSS&C

Overview

Manage regulatory clinical trial applications or maintenance activities independently for an assigned product portfolio and selected countries/regions, under supervision, in collaboration with study teams, country leads and line functions.

What you'll do

• Ensure clinical trial applications or maintenance submissions are prepared on time and in compliance with regulations, guidelines and Novartis processes and system requirements.
• Manage the assigned product portfolio and country/region knowledge.
• Use regulatory expertise to identify issues, gaps and tradeoffs to avoid or minimize delays and achieve timely submissions and approvals.
• Manage timely responses to health authority (HA) queries and collaborate with the regulatory lead to prepare strong justifications addressing regulatory gaps.
• Enter product-specific attributes accurately in compliance databases and applicable RIMs.
• Facilitate preparation and finalization of documents for HA interactions for matters of low complexity.
• Contribute to non-project initiatives focused on productivity, continuous improvement and automation.
• Share knowledge on specific topics and support other associates within Regulatory Affairs.

What you'll need

• Science-based BS or MS with requisite experience and demonstrated capability.
• Regulatory affairs experience of 9 to 13 years (at least 7 years of relevant experience) 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, automation and operational excellence initiatives.
• Understanding of 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.

Nice to have

• Advanced degree (MD, PhD, PharmD).
• Skills: Data Analysis, Regulatory Compliance, Waterfall Model.

Details

• Location: Hyderabad (Office).