Regulatory Affairs Specialist

Responsibilities in this position will include:

Supports preparation andmaintenance of program annual reports, and may support CMC, nonclinical,pharmacovigilance and other routine regulatory programs and other routineregulatory filings.

Conducts internetsearches on regulatory topics to support development programs, and departmentand company compliance.

Provides technicalreview of data or reports to be incorporated into regulatory submissions toensure scientific rigor, accuracy, and clarity of presentation.

Coordinates, prepares,or reviews regulatory submissions for domestic and/or international projects.