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 are not limited to: . Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance, Lead and implement all global CMC submission activities (planning, authoring, reviewing,coordination, submission) for assigned projects/products. . Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. . Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC, global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. . Proactively communicate CMC regulatory strategies, risks & key issues throughout the life cycle in a timely manner to project teams and other stake holders. Represent department in cross-functional project teams as appropriate. . Prepare and communicate CMC Risk Management Assessments, contingency plans, and Lessons learned on major submissions and escalate with management as appropriate. . Initiate and lead Health Authority interactions and negotiations as appropriate setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. . Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt . Distribution of marketing samples (where applicable) Diversity & Inclusion / EEO Minimum Requirements . Collaborating across boundaries, Cross Cultural Experience . Operations Management and Execution . Project Management . Business Mindset, Interpersonal Savvy . Operational Excellence, Project Excellence . Stakeholder Engagement 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:

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