Provides strategic advice and facilitated execution of regulatory processes during product development. Led delivery of key milestones such as marketing authorization applications, paediatric investigation plan, orphan designation, PRIME application. Managed team of regulatory experts and developed team capabilities. Project managed client projects. Performed business development, by building networks and writing and presenting project proposals. Supported companies in transitioning towards being a MA-holder.

Gave regulatory strategic input and facilitate execution of regulatory processes in all stages of the product life cycle, including development of briefing books, attending Health Authority meetings and regulatory lead marketing authorization applications. Contributed to business development.

Regulatory lead within global development team for new inhalation compound from Phase III to launch in EU and Emerging Growth Markets and driven regulatory life cycle management for monoclonal antibody, including registrations of new formulation and new indications. - Defined HA meeting strategies, including briefing book preparation, and subsequently led effective scientific advice and pre-submission meetings. - Developed and executed regulatory strategies in support of MAA, line extensions and (major) variations.- Provided regulatory input to development programs, supported development of protocols and lead teams in preparation of CTAs.- Thorough understanding of PhV, contributed to and detailed review of PSURs, RMPs, PASS, DSURs etc.

Led Marketing Authorization Application through MRP procedure. Coached and developed regulatory affairs managers and interns to independently working associates. Led implementation EU legislation on User Consultation of Package Leaflets at company level.

Author of global labeling documents, including the CCDS, for different therapeutic areas. Regulatory lead in product license maintenance.

Two year trainee program, with focus on personal development and project management.