- Entry level
- No Education
- Salary to negotiate
200+ projects in development. 20 major approvals. 20 major submissions. And that’s just in 2018. This is your chance to help reimagine medicine in 2019. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative. Take the first step by looking at our track record of amazing accomplishments on behalf of our patients. Novartis employees have enjoyed long, rewarding careers working with colleagues around the world via flexible, family friendly arrangements. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career.
Global Regulatory Affairs leader supporting the development of digital and other innovative technologies, as stand alone or in combination with Novartis products. This role supports Global Program Teams (GPTs) and Digital Development teams as a core team member and functions independently with minimal supervision to define and implement the global regulatory strategy for the development, registration and approval/post approval of novel technology. The GPRD-Innovation can serve as the RA representative on a GPT or partner with the Development Unit (DU) RA representative (if any) on the GPTs to ensure appropriate digital and device strategy. This role also serves as the expert enterprise-wide on key topics such as Software as a Medical Device (SaMD), the development and use of sensors and novel endpoints, novel clinical trial approaches, block chain, AI and other emerging technologies. The GPRD Innovation will also be highly externally engaged, participating in industry groups, consortia and with global Health Authorities (HAs) to drive adoption, acceptance and development of standards for novel technological approaches in drug development and evolving digital medicine categories.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph. D, PharmD) preferred. Fluency in English as a business language. Additional language is an asset. • Strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices (preferred). • Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry. • Leadership role in HA negotiations in multiple regions. • 6-8 years involvement in regulatory, drug/biologic development and medical device/pharmaceutical combination products spanning activities in Phases I-IV in the following areas: 1. Innovation in regulatory strategy. 2. Prior history with post-marketing/brand optimization strategies and commercial awareness preferred. 3. Involvement in dossier submissions and approvals. 4. HA negotiations 5. Drug regulatory submissions and commercialization in major regions. 6. Proven ability to analyze and interpret efficacy and safety data. 7. Regulatory operational expertise. 8. Application development, software development and digital products 9. Strong history of leadership.
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.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Division Global Drug Development
Business Unit REG AFFAIRS GDD
Site East Hanover, NJ
Company/Legal Entity Novartis Pharmaceuticals
Functional Area Research & Development
Job Type Full
About the company
Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Our company culture is guided by high ethical standards. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision.