Regulatory Coordinator / Senior RC

329414BR
Oct 08, 2021
India

Job Description

200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide

Your Responsibilities:
Your responsibilities include but not are limited to:
• To set registration plan, to perform product registration in accordance with registration and launch plan, and maintain product license with local regulation and global compliance strategy.
• Review new projects and set development plan (timeline etc.) in collaboration with Global DRA and related CPO functions (Marketing, HE&P and CD&MA etc.)
• 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.)
• Cultivate and maintain good relations with internal and external partners The Regulatory Coordinator is responsible for providing operational regulatory and compliance support on development projects/major line extensions through development, registration, and approval including post approval commitments.
• Handle and prepare Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations.
• Contribute to Module #1 documents including FDA forms and cover letters for maintenance submissions with management oversight . Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submission-related activities.
• Support US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable 5. Manage the user fee registration requests 6. Manage and execute drug shipment ticket review process (US) .In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc . Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What You’ll bring to the role:

• Operations Management and Execution Project Management Functional Breadth Cross Cultural.
• Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational skills.
• Excellent written/spoken communication skills.
• High level understanding of Regulatory quality, standards and policies.
• University or College Degree in any field or life science with relevant industry experience


Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re
proud of this, we know there is so much more we could do to help improve and
extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found
at the intersection of medical science and digital innovation. That a diverse,
equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned
by integrity, curiosity and flexibility. And we can reinvent what's possible, when we
collaborate with courage to aggressively and ambitiously tackle the world’s
toughest medical challenges. Because the greatest risk in life, is the risk of never
trying!

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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329414BR

Regulatory Coordinator / Senior RC

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