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Job Details


Novartis

Global Program Regulatory Manager (Neuroscience)

Pharmaceuticals

All

Full Time

On Site

No

East Hanover, New Jersey, United States

About the Role

Location: East Hanover, NJ #LI-Hybrid

The Global Program Regulatory Manager works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the Regulatory Affairs Global Program Team (GPT) representative and/or Global Therapeutic Area Lead for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and may have responsibility for leading regional RA sub teams.

Key Responsibilities:
• Provide input into regulatory strategies and take responsibility for their subsequent implementation
• Manage operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes
• Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required
• Lead or coordinate Health Authority meetings in assigned region(s)
• Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)
• Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification
• Handle internal systems and tools that are needed to assess compliance