Regulatory Affairs Specialist Ii

**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office- Acts as liaison with internal stakeholders in the provision of these services.- Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of the final submission package.- Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.- Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects.- Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.- Acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.Education and Experience:- Bachelor's Degree; degree in Pharmacy or Life Science is an advantage- Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered