VP of Regulatory Affairs in Chicago, IL

The successful applicant will have demonstrated the expertise to act as a credible, influential, respected spokesperson during interactions with international regulatory agencies, and ensure appropriate, proactive communication with agency officials to assure expedient and efficient review and approval of submissions. ? Direct the development of regulatory strategy to deliver global registrations for the biologic products platform.? Oversee the regulatory support for lifecycle management of biologic products globally.? Represent the company in the interactions with global regulatory authorities and external business venues such as technical meetings, regulatory forums and with industry groups to leverage company positions and influence legislation and guidelines impacting the regulatory environment.? Manage regulatory issues related to the global development of biologic products to compile high quality global core dossiers, realize on-time approvals and support tactical promotion of marketed product.? Ensure that regulatory development and lifecycle resources are focused on harmonized goals in line with the Program Management, Research & Development, Global Marketing and Corporate Development and Commercial for biologic products. Skills/Background Education/Certification Background The successful applicant will be academically trained in Life Sciences or related disciplines and with a work experience of significant accomplishments in regulatory affairs. She/he will possess the following