Job Description:
Our client is looking for a 2-5 year Regulatory Project Manager to support their growing regulatory team on multiple drug submissions. This role oversees the management, tracking and maintenance of open regulatory applications (INDs and NDAs), Agency Development and Post-approval commitments, and Global Partnership commitments, all with an emphasis on high-quality, timely submissions to Regulatory Agencies (primarily FDA). Submissions include IND’s and NDA’s (505(b)(2) NDAs, Annual Reports, Amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans. The Regulatory PM will be expected to provide input to objectives and goals for the functional group and organization. It is expected that this professional has experience working in a cross functional environment preferably within a small organization.
Skills:
Regulatory Project Management
IND / NDA
Gantt Charts / Microsoft Project
Global Experience – Plus
Education:
BS
PMP – Plus
RAC Certification – Plus
Remote: BACKFILL- Regulatory Project Manager (233243)
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