Novartis Regulatory Coordinator Recruitment Hyderabad

Novartis Regulatory Coordinator Recruitment Hyderabad: Apply Now

Are you an experienced professional in regulatory affairs looking for a new challenge? Novartis, a global leader in pharmaceuticals, is hiring a Regulatory Coordinator in Hyderabad. If you have a minimum of 3 years in the pharmaceutical industry and at least 1-2 years of regulatory experience, this could be the perfect opportunity for you.

Job Overview

Position: Regulatory Coordinator
Location: Novartis, Hyderabad
Qualification: Minimum of 3 years of pharmaceutical experience with 1-2 years in regulatory affairs
Application Deadline: Open until filled

Novartis is dedicated to improving and extending people’s lives by advancing medical science and digital innovation. As a Regulatory Coordinator, you will play a critical role in ensuring the timely submission of health authority documents and maintaining regulatory compliance.

Key Responsibilities

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
• Foster and maintain good relations with internal and external stakeholders
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

• Health Authority Submissions:
  • Independently manage and prepare routine submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendments, and New Investigator Submissions.
  • Ensure timely submissions in accordance with FDA regulations and Novartis requirements.
• Documentation and Compliance:
  • Contribute to Module #1 documents including FDA forms and cover letters for submissions.
  • Conduct monthly reconciliations to ensure compliance with FDA regulations.
  • Manage US regulatory compliance activities and update the compliance database (DRAGON).
• Project Management:
  • Identify issues, gaps, and trade-offs affecting optimal submission timelines.
  • Manage user fee registration requests and execute drug shipment ticket reviews.
  • Support clinical functions on regulatory compliance activities and requirements.
• Team Collaboration:
  • Assist regulatory managers in compiling and releasing submissions to regulatory agencies.
  • Participate in kick-off meetings for NDA/IND annual reports and perform QC of approved labels.

Role Requirements

• Experience: Minimum of 3 years in the pharmaceutical industry with 1-2 years of regulatory experience preferred.
• Skills: Good communication, negotiation, and proactive personality. Ability to plan, prioritize workload, and work in a matrixed environment.
• Technical Skills: Proficiency in publishing/Regulatory Operations is desired.

Benefits of Working at Novartis

• Competitive Pay: Attractive compensation package with performance-based rewards.
• Employee Benefits: Comprehensive benefits tailored to support you and your family.
• Professional Development: Opportunities for continuous learning and growth.
• Inclusive Environment: A diverse and inclusive workplace where everyone is respected and valued.

How to Apply

Interested candidates should prepare a comprehensive resume detailing their educational background and relevant experience. To apply, visit our Novartis Careers page.