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Regulatory Affairs Associate Director 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Full-Time/Part-Time Full-Time  

Represent Regulatory Affairs on assigned project (both internal and external cross-functional teams) 

Provide regulatory assessment of due diligence requests to support new business development activities  

Serve as primary interface with FDA and other regulatory agencies for assigned projects 

Manage regulatory filings (IND, NDA, ANDA, BLA, etc.), including authorship of critical documents, as needed 

Manage operational aspects of preparing compliant submissions to regulatory agencies 

Establish and manage timelines associated with regulatory submissions 

Manage archive of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms 

Provide regulatory guidance on requirements for development projects and post-approval changes, as required, for assigned projects 

Establish regulatory strategy for assigned projects with input from project teams 

Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership Team (ELT) meetings and presentations 

Keep abreast of current regulations and regulatory guidance, assessing impact to assigned projects and internal processes 

Assist in preparing budgets and reviewing invoices on assigned projects, as needed. 

Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department 

Location Kansas City, MO  

This position is currently not accepting applications.

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