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
- 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.
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Novartis Regulatory Coordinator Recruitment Hyderabad: Apply Now[/caption]
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.
https://pharmastuff.org.in/job/novartis-regulatory-coordinator-recruitment-hyderabad
