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Global Program Regulatory Manager/Sr (Immunology)




East Hanover, New Jersey, United States

Location: East Hanover, NJ #LI-Hybrid<br><br>About the Role: <br>The Global Program Regulatory Manager works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the RA 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.<br><br>Key Responsibilities:<br>• Provide input into regulatory strategies and take responsibility for their subsequent implementation<br>• Manage operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes<br>• Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required<br>• Lead or coordinate Health Authority meetings in assigned region(s)<br>• Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)<br>• Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification<br>• Handle internal systems and tools that are needed to assess compliance<br><br>[#video#{#400,300#}#/video#]