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
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