* Preparation of full high quality submissions to FDA * Represent RA on project teams and providing regulatory guidance * Review technical documents for cGMP and regulatory compliance * Strategize responses to FDA to afford swift approval * Evaluate post approval changes to determine appropriate filing strategy * Coordinate receipt of documentation per established timelines * Communicate activities, timeline and progress to Sr Director of RA

* Maintained several Type III Drug Master Files (DMFs) for US and Canada * Assessed changes and provided RA impact for various product lines * Liaison between health authorities and the business regarding regulatory concerns * Heavy interaction with global colleagues to support of life cycle management of products * Prepared letters of authorization (LOA) for pharmaceutical customers * Negotiated with FDA and Health Canada on information contained in the DMF * Participated on several core teams for product development projects * Managed one regulatory coordinator who supported preparation and filing of submissions * Communicated key US regulatory topics to business via monthly newsletter * Contributed to the Blue Ocean Strategy Initiative which targeted emerging business opportunities in relation to patient compliance to treatment to chronic diseases (i.e. diabetes, hypertension and asthma)

* Provided regulatory feedback on project teams for pre and post approval submissions * Interacted with internal departments and contract facilities to obtain submission documents * Determined regulatory impact to proposed changes and provided submission strategy * Transitioned regulatory submissions from paper to electronic documents * Developed procedures for electronic submissions according to applicable FDA guidance documents * Defined timelines for electronic preparation/review and tracked all submissions activity * Mentored and guided less experiences regulatory associate