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Novartis Jobs for Freshers | Associate, US Labeling, GRA | Shape the Future of Sandoz | Join an Inclusive Work Environment | www.placement-officer.com

Novartis is seeking talented freshers to join their team as Associates in the US Labeling, GRA department. This is a unique opportunity to contribute to the growth of Sandoz, a leading global player in Generics and Biosimilar medicine. As a part of this purpose-driven organization, you'll play a key role in preparing, reviewing, and compiling regulatory labeling deliverables for FDA submissions. Take ownership of the entire labeling process and ensure compliance with FDA guidelines and internal procedures. Join us in shaping the future of Sandoz and making a real difference in the healthcare industry. Apply now and be a part of our diverse and inclusive work environment.

Job Description

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz… are you ready to make a difference?

Position Purpose:
Responsible for providing Labeling supports to Sandoz’ business operations by preparing, re-viewing, and compiling high-quality and compliant regulatory labeling deliverables for FDA sub-missions based on Reference Listed Drug Labeling, FDA guidelines and regulations, and Sandoz internal policies and procedures.

Your Key Responsibilities:

Your responsibilities include, but not limited to:
• With direction, prepare, review and compile high quality regulatory labeling deliverables for FDA in accordance with both FDA and internal timelines. Some common labeling deliverables are, SPL, side-by-side with annotation, document with track changes and any other required documents per process.
• Accountable for the overall Drug Listing labeling process (creation, review and submission) of SPL submission to FDA with and without highlights, and maintenance of all labeling files in accordance with internal procedures.

• Takes ownership of the entire process involving the creation, preparation, review, approval and management of pharmaceutical labeling artworks for FDA submission based on Reference Listed Drug labeling, FDA requirements and company requirements. Also responsible for managing and tracking submission processes to ensure timely delivery to FDA.
• Responsible to identify changes needed from FDA approved labeling including updates to Reference Listed Drug, USP and new regulatory updates. Responsible for the product registrations, maintenance of product drug listings and delisting, NDC number posting to NDC directory, and accuracy of labeling posted to DailyMed.

• Responsible for managing artwork change control per policy and procedures. Actively participates in team meetings, independently tracks FDA labeling updates and implements safety-labeling changes based on departmental work instructions. Provides labeling support and guidance to internal and external stakeholders.
• Provides regulatory labeling subject matter expert support and work closely with cross-functional groups by providing appropriate regulatory requirements/guidance.

• Stays current with emerging regulatory labeling guidance, and industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices. Reviews labeling change control requests for completeness and accuracy. Assesses the impact of the changes as they relate to approved BLA, ANDAs and/or NDAs and communicates the impact to his/her manager.
• Responsible for ensuring the accurate and timely preparation of all essential labeling components, including but not limited to physician insert, patient insert, carton/ carton label, vial label, printed foils, etc. Other functional duties as requested by management.

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.

Minimum requirements

What you’ll bring to the role:
Desirable Requirements:
• Master’s degree in a scientific discipline.
• At least 1-2 years of relevant experience in Regulatory Labeling domain with exposure of working in global organization in generics setting is preferred.

Why Sandoz?

Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com).