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Analyst, Regulatory Affairs

Duties

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.

Skills

* 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.

Education

Master Degree in biology or other life sciences discipline REQUIRED, or advanced degree ( PhD, PharmD) 7+ years experience required

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