• support regulatory strategy implementation for development programs • lead and prepare regulatory submissions (authoring, timeline planning, etc.) • assist in developing and implementing global regulatory strategies • establish and maintain department regulatory processes • develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required • actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed • contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization • lead the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications • coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments as needed • develop and manage project timelines for regulatory submissions • maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission • provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages • track submissions, correspondence, and commitments with health authorities • provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional • provide regulatory intelligence and research to the team as needed • write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate • lead, direct, manage, coach/mentor, and evaluate direct reports