Prepare, coordinate, lead and author, all aspects of regulatory submissions (e.g., clinical/marketing submissions, annual reports, investigator brochures, amendments, briefing book for health authority meetings, responses to health authority information requests, adverse event reporting) with internal and external cross-functional teams. Clinical Study Teams, Project Teams, Commercial) and with external business partners such as CROs, consultants, etc. to generate and refine the product development strategy, advise team members of major regulatory issues and provide possible solutions and/or mitigation strategies.