Support the Global Regulatory Policy Team in the following regulatory policy activities:
* Review and assess recently published global regulatory legislation and policies impacting development of treatments for rare diseases, communicate the impact to management and project teams.
* Lead teams on generation of comments on draft guidances; proactively provide comments on new regulatory guidances, including working with coalition groups.
* Actively monitor developments and predict policy changes in the rare disease space.
* Actively communicate policy priorities, to educate and engage both internal and external stakeholders in building a favorable regulatory policy environment.
* Provide strategic logistical support for managing policy calendars and deliverables.
* Develop and manage internal policy publications.
* Develop, track and manage reguatory conferences and inform internal stakeholders of such conferences.
* Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.
* Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs and/or policy
* Strong verbal and written communication skills
* Strong project management skills
* Proficient with computer and standard software programs
* Organizational skills
* Communication skills, excellent verbal, written and presentation skills
* Very strong attention-to-detail combined with ability to see big picture and understand business need
* Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders.
Master Degree in biology or other life sciences discipline REQUIRED, or advanced degree ( PhD, PharmD) 7+ years experience required