349378BR
Jul 21, 2022
India

Job Description

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.

Your Responsibilities:
Your responsibilities include but not are limited to:

• Regulatory Strategy: Responsible for implementing regulatory strategy and managing operational activities for assigned regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents. Coordinates and implements regulatory readiness with other line functions, Country Organizations and key opinion leaders. Works with RA GPT representative and/or GTAL to interact with regulatory.


• HA Interactions: Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL. Interacts directly with HAs as appropriate in meetings with RA GPT representative and/or GTAL. Coordinates and plans rehearsals for HA meetings. Facilitates preparation and finalization of briefing books. Develops and implements plans for timely response to HA requests and coordinates responses. May serve as local HA liaison depending on location (e.g., FDA or EMA.

• Submissions and Approvals: Responsible for integrating global strategy into regional submissions worldwide. Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval. Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Contributes to development and implementation of plans to avoid/minimize clock stops during submission review.Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).

• Prescribing Information: Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP. Assists with generating local PIs and ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive. Contributes to identifying potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.

• Regional Excellence and Compliance: Responsible for finalization and on time submission of annual reports and renewals across assigned regions. Responsible for appropriate entering and quality of product specific attributes in compliance database. Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.

• Promotional/Non-promotional Review: Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines.




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:

• Science based BS or MS with requisite experience and demonstrated capability. Fluency in English as a business language. Additional language is an asset.
• Experience with regulatory submission and approval processes in 1 or more major region.
• Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry.
• 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following ares - Innovation in regulatory strategy. Understanding of post-marketing/brand optimization strategies and commercial awareness preferred. Involvement in an dossier submission.
• Basic organizational awareness (e.g., interrelationship of departments, business priori
• Strong interpersonal, communication, negotiation and problem solving skills.

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

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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349378BR

Associate Global Prog Reg Manager (AGPRM) - LCM

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