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 include but not are limited to: . 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, including identification of gaps or risks in global strategic plan for assigned regions. . Partners with regions to align on regulatory strategy in order to fulfill business objectives. . Implements RFP across assigned regions. . Works with RA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy . 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 consultants/advisors for strategy input and challenge. . Represents RA on or leads sub-teams as required. Diversity & Inclusion / EEO Minimum Requirements . Experience with regulatory submission and approval processes in 1 or more major regions. . Experience in a global/matrix environment or crossfunctional teams in the pharmaceutical industry. . Experience in HA negotiations. . 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: o Innovation in regulatory strategy. o Understanding of post-marketing/brand optimization strategies and commercial awareness preferred. o Involvement in an dossier submissions and approvals o HA negotiations. o Drug regulatory submission and commercialization in region. o Analysis and interpretation efficacy and safety data. 4 o Regulatory operational expertise. . Strong interpersonal, communication, negotiation and problem solving skills. . Basic organizational awareness (e.g., interrelationship of departments, business priorities). 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:

foundit