Associate Director, Regulatory Affairs Strategy - General Medicine

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Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidances and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron's development and marketing objectives within specified timelines.

• Liaison responsible for communication with FDA and other health authorities for assigned programs
• Management of all regulatory activities associated with Regeneron drug development programs
• Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals
• Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, include preparation and maintenance of IND or CTA filings
• Oversee development of all regulatory filings in support of program
• Perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions
• Perform reviews of clinical protocols and of clinical and preclinical study reports with respect to clarity, completeness, and regulatory requirements
• Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages
• Accountable for ensuring the completeness and accuracy of information provided in regulatory submissions
• Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation
• Management of the planning, preparation and submission of licensing applications
• Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) and MAA
• Assist with the scientific writing and review of application
• Evaluate conformance with the regulatory requirements, clarity, and completeness
• Manage timelines/budgets with project management as appropriate and provide progress updates to senior management
• Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
• Provide training on applicable requirements for scientific staff as required

This role requires

• An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred
• A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience
• Research laboratory, process development or manufacturing experience with biotechnology products highly desirable
• Must possess excellent written and verbal communication skills