Global Regulatory Manager, GRSS&C

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; Sur place; INR 1 500 000 - 2 100 000; Plein temps

Résumé du poste

IN10 (FCRS = IN010) Novartis Healthcare Private Limited is seeking a Regulatory Global Trial Management (GRM-RACS) professional to independently manage regulatory clinical trials and maintenance activities. The role focuses on delivering complete, compliant submissions and timely approvals across assigned portfolios.

Ideal candidates have a science-based BS/MS, and an advanced degree is preferred. 9–13 years in regulatory affairs with a track record in major country submissions is desirable.

Qualifications

• Requires science-based BS or MS with relevant experience.
• Advanced degree (MD/PhD/PharmD) preferred for regulatory roles.
• Experience in regulatory submissions and approvals in major countries.

Responsabilités

• Manage regulatory submissions for clinical trials or maintenance within assigned portfolio.
• Collaborate with study team, Country lead and line functions to ensure quality, compliance, and timely approvals.
• Respond to HA queries and prepare strong justifications to address regulatory gaps.
• Enter product attributes in regulatory databases and compliant systems.
• Support productivity, continuous improvement and automation initiatives within Regulatory Affairs.

Connaissances

Data Analysis

Regulatory Compliance

Waterfall Model

Formation

Science BS/MS

Advanced degree (MD/PhD/PharmD) preferred

Description du poste

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 Requirements

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

About us

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.