Associate Global Regulatory Manager GRSS&C

Novartis India; Hyderabad; On-site; INR 700,000 - 1,500,000; Full time

Job summary

Novartis India is seeking a Regulatory Affairs professional to manage regulatory submissions and maintenance activities for multiple countries, ensuring timely, compliant, and scientifically accurate submissions. You will collaborate with study teams and Country leads to maintain country knowledge and improve processes.

Ideal candidates will have experience in global/matrix environments, strong communication skills, and be proactive in identifying gaps to minimize delays in approvals.

Qualifications

• Experience with regulatory submission and approval processes in major countries, including planning, execution, reporting, regulatory review, compliance, and submission activities.
• Ability to participate in process improvements, simplification, automatization, and operational‑excellence initiatives.
• Understanding of safety and efficacy data and product labels.
• Reliable, timely, accurate, and proactive communication skills.
• Experience in a global/matrix environment or cross‑functional teams within the pharmaceutical industry.
• Desirable: Data Analysis, Regulatory Compliance, Waterfall Model.

Responsibilities

• Manage regulatory clinical trials or maintenance activities under supervision for assigned product portfolio and countries/regions.
• Ensure regulatory submissions are prepared on time, compliant with regulations, Novartis processes, and system requirements.
• Collaborate with study team, Country lead, and line functions to ensure submissions are complete, scientifically accurate, and compliant.
• Manage assigned product portfolio and maintain country/region knowledge.
• Identify issues and gaps using regulatory expertise to avoid delays and achieve timely submissions and approvals.
• Enter product‑specific attributes in compliance databases and applicable RIMs accurately.
• Facilitate preparation and finalization of documents for HA interactions for low‑complexity matters.
• Contribute to productivity, continuous improvement, and automation initiatives.
• Share knowledge and support other associates within Regulatory Affairs.

Skills

Data Analysis

Regulatory Compliance

Waterfall Model

Cross-functional collaboration

Regulatory submissions

Process improvements

Automation

Job description

ROLE

• Manage regulatory clinical trials or maintenance activities under supervision for assigned product portfolio and countries/regions.
• Ensure clinical trial applications and maintenance submissions are prepared on time, compliant with regulations, guidelines, Novartis processes, and system requirements.
• Collaborate with the study team, Country lead, and line functions to ensure high‑quality, complete, well‑organized, scientifically accurate, and compliant submissions are prepared, reviewed, and approved.
• Manage assigned product portfolio and maintain country/region knowledge.
• Identify issues, gaps, and trade‑offs using regulatory expertise to avoid/minimize delays and achieve timely submissions and approvals.
• Enter product‑specific attributes in the compliance database and applicable RIMs accurately.
• 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 activities.
• Ability to participate in process improvements, simplification, automatization, and operational‑excellence initiatives.
• Understanding of safety and efficacy data and product labels.
• Reliable, timely, accurate, and proactive communication skills.
• Experience in a global/matrix environment or cross‑functional teams within the pharmaceutical industry.
• Desired skills: Data Analysis, Regulatory Compliance, Waterfall Model.