Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
817 million. That’s how many lives our products touched in 2018. And while we’re proud of that, 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?
The Novartis Institutes for Biomedical Sciences (NIBR) is world-renowned for its groundbreaking science in drug development including cell and gene therapy. You will work closely with scientists of NIBR on innovative medicines in diseases with a high unmet medical need that are based on NIBRs scientific discoveries. As part of the NIBR team, the early development regulatory manager will contribute to bring innovative novel therapies to patients as quickly as possible. The regulatory manager will play a critical role in defining the optimal regulatory strategy for first in human (FIH) and proof of concept (POC) studies and contribute to the long-term strategy of the projects to registration in collaboration with RA colleagues in Global Drug Development (GDD). Join us at the scientific frontier!
Your Responsibilities: Your responsibilities include, but not limited to:
? You will be responsible to provide input into global regulatory strategy for early development compounds. ? You will contribute to regulatory innovations (e.g. novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways). ? You will contribute to identification of regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approval. ? You will be a key contributor in the core project Teams to the overall project development strategy. ? You will work in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator Brochures, end of trial notifications, submission of CSR etc. ? You will participate in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs.
What you’ll bring to the role:
• A Science based BS or MS with requisite experience and demonstrated capability. Scientific curiosity is a must in this role. Advanced degree (MD, Ph D, PharmD) is a plus. Fluent English (oral and written) as a business language. • 2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU / US regulatory affairs. Additional knowledge of other regions is an asset. • Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline, as well as with biologics is an asset. • Strong interpersonal, communication, negotiation, problem solving skills and ability to work in a global/matrix environment. Why consider Novartis?: 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.
We are Novartis. Join us and help us reimagine medicine.
Internal Number: 260634BR
About Novartis Pharmaceuticals
The Pharmaceuticals Division of Novartis is recognized worldwide for the innovative medicines we provide to patients, physicians and healthcare organizations.
This growing business develops and markets patent-protected prescription drugs for important health needs. Our products are concentrated in major therapeutic areas: Cardiovascular/Metabolism, Oncology, Neuroscience, Dermatology, Arthritis Bone, Respiritory, Infectious Disease, Transplant, Opthalmics, GI, Urinary.
We have received 15 new pharmaceutical product approvals in the US since 2000, the most of any pharmaceutical company. Our current product portfolio includes more than 45 key marketed products, many of which are leaders in their respective therapeutic areas. The product development pipeline involves nearly 140 projects – including potential new products as well as potential new indications or formulations for existing products – in various stages of clinical development.
Industry experts have ranked Novartis as a leader for having one of the best combinations of organic growth, pipeline opportunities, and low patent-risk exposure among major companies in the pharmaceuticals industry