Global Program Regulatory Director- Innovation

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 11 months ago

Job Description:
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.

Employment Type

Regular



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Global Program Regulatory Director- Innovation

Novartis Pharmaceuticals