Job Description

About the role

Your responsibilities include, but are not limited to:

• Independently manage and prepare routine 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/non-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
• Proactively identify issues, gaps, and trade-offs affecting optimal and timely submission. Independently manage 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
• Independently manage the user fee registration requests. Independently 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
• Where appropriate, participating in kick-off meetings for NDA/IND annual reports and QC of NDA annual reports from previous versions (US). Where appropriate, perform QC of approved label versus previous versions with adequate management oversight

Role Requirements

• Minimum of 3 years pharmaceutical experience with a minimum of 1-2 years of regulatory experience preferred.
• Prior publishing/Regulatory Operations experience desired.
• Good communication and negotiation skills.
• Proactive personality.
• Fast and flexible, focused on timely delivery and stretch targets
• Ability to plan and prioritize workload
• Ability to work in a matrixed environment.
• Ability to build effective relationships across teams/projects.

WHY 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 here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team\'s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Research & Development

Division

Development

Business Unit

REG AFFAIRS GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

Novartis