Global Regulatory Manager GRSS&C

Growth For Impact; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Growth For Impact in Hyderabad, India, seeks a Regulatory Affairs professional to manage regulatory submissions and maintain compliance across major markets. You will collaborate with study teams, country leads, and line functions to ensure timely, scientifically accurate filings that meet regulatory requirements.

You will enter product-specific attributes into compliance databases, support HA interactions for low-complexity matters, and contribute to productivity and automation initiatives

Qualifications

• Experience with regulatory submission and approval processes in major countries.
• Ability to participate in process improvements, simplification, automation, and operational-excellence initiatives.
• Understanding of safety and efficacy data and product labels; reliable and proactive communication.
• Awareness of interrelationships among departments in a global setting.

Responsibilities

• Manage regulatory clinical trials or maintenance activities independently.
• Collaborate with study team, country lead, and line functions to ensure compliant submissions are prepared, reviewed, and approved on time.
• Ensure submissions are prepared on schedule and in compliance with regulations, Novartis processes, and system requirements.
• Manage assigned product portfolio and maintain country/region knowledge.
• Use regulatory expertise to identify issues and minimize delays for timely submissions and approvals.
• Enter product-specific attributes in compliance database and applicable RIMs.
• Facilitate preparation and finalization of documents for HA interactions for low-complexity matters.
• Contribute to non-project initiatives focused on productivity, continuous improvement, and automation.
• Share knowledge on topics and support other associates within Regulatory Affairs.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory compliance

Project management

Global/matrix environment

Data interpretation

Job description

ROLE

• – Manage regulatory clinical trials or maintenance activities independently.
• – Collaborate with the study team, country lead, and line functions to ensure high‑quality, complete, well‑organized, scientifically accurate, compliant submissions are prepared, reviewed, and approved on time.
• – Ensure clinical trial applications or maintenance submissions are prepared on schedule and in compliance with regulatory regulations, guidelines, Novartis processes, and system requirements.
• – Manage assigned product portfolio and maintain country/region knowledge.
• – Use regulatory expertise to identify issues, gaps, and trade‑offs to avoid/minimize delays and achieve timely submissions and approvals.
• – Enter product‑specific attributes in the compliance database and applicable RIMs.
• – Facilitate preparation and finalization of documents for HA interactions for low‑complexity matters.
• – Contribute to non‑project initiatives focused on productivity, continuous improvement, and automation.
• – Share knowledge on specific topics and support other associates within Regulatory Affairs.

REQUIREMENTS

• – Experience with regulatory submission and approval processes in major countries, including planning, execution, reporting, regulatory review, compliance, and submission.
• – 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.
• – Basic organizational awareness of interrelationships among departments.
• – Experience working in a global/matrix environment or cross‑functional teams in the pharmaceutical industry.
• – Data