*Partner with health authority project managers and review teams to represent their perspective in the Company.
*Develop regulatory strategy for development and commercial projects.
*Provide regulatory guidance and support to various departments including Clinical Research, Manufacturing, Commercial and Business Development.
*Analyse regulatory history and competitor information to provide regulatory intelligence across relevant therapeutic areas and indications.
*Review promotional and non-promotional materials for marketed products, and lead the Medical-Legal-Regulatory Review process
*Coordinate project regulatory operations services.
*Manages, drafts, and aids in securing internal approval of FDA meeting requests and briefing books.
*Manages labelling documents, including preparing package inserts, as well as aiding in quality control of labelling submissions.
*Responsible for managing the compilation, submission and maintenance of INDs, NDAs, amendments and supplements.
*Support and participate in the Company's due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.
JOB REQUIREMENTS
Technical Skills/Knowledge
*7+ years of regulatory experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
*Experience in working with development project teams in a regulatory leadership role.
*Experience with FDA regulations and their impact across the entire development cycle including promotion of pharmaceutical products and labelling.
*Experience across multiple therapeutic areas is a plus.
*Ability to provide strategic and operational guidance across all levels of the company and external vendors.
