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Director, Regulatory Policy & Intelligence (347415BR)


Executive Director



Rockville, Maryland, United States

1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. <br>We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.<br><br>Facilitate application of regional regulatory requirements and intelligence to provide strategic direction and product advocacy in global development to achieve Regulatory Affairs enterprise objectives and enable regulatory compliance<br><br>You're responsibilities include, but are not limited to:<br><br>• Provide regular communications and briefings to Global and Regional Policy Heads on relevant global regulatory policy issues<br>• Participate in internal product team meetings to provide regulatory policy context for business decisions<br>• Provide strategic regulatory advice to RA colleagues on drug development projects and registration, and marketed products in preparation for HA meetings.<br>• Develop training materials and participate as a facility member on new and emerging regulatory requirements for RA colleagues and other line functions<br>• Analyze impact of important emerging regulatory policies and new requirements on Novartis projects and business.<br>• Prepare and coordinate internal customer feedback on proposed laws, regulations and guidances, to ensure consideration of Novartis positions by trade organizations<br>• Represent Novartis on external committees e.g. trade associations<br>• Collaborate with Novartis Corporate Affairs to shape emerging legislative proposals<br><br>[#video#{#400,300#}#/video#]