Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 advantagePrevious regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered