Avid Bioservices Inc (CDMO)

[eam07]

NEW job posting on peregrine site.. Regulatory Operations Manager


Company Information Peregrine Pharmaceuticals, Inc.
14282 Franklin Ave
Tustin, CA 92780
Website: http://www.peregrineinc.com
Job Description Summary The candidate will assist with the timely preparation and submission of organized and scientifically valid applications to regulatory agencies in eCTD format. Knowledge of regulatory operations and electronic submission requirements is a must. The position requires close collaboration with staff and CROs to provide submission strategy and timing in a global clinical development environment as needed. The role will ensure that Peregrine practices are in conformance with the latest Health Authority and Industry submission standards. Job Requirements include the following. Other duties may be assigned. Responsible for formatting, publishing, and submission of regulatory documents (IND, BLA, MAA, NDA, CTA, CTX, IMPD) in eCTD format and coordination of submissions independently and in a team setting in time-intensive situations. Responsible for organizing and maintaining regulatory files. Understands IND and BLA life cycle and maintenance requirements. Assists with the writing and critical review of regulatory documents as needed. Proficiency in a major regulatory e-submission software as well as Microsoft Office Suite (Word, Excel, PowerPoint, Office) and SharePoint. Familiarity with NextDocs a plus. Demonstrates extensive knowledge of regulatory submission requirements and regulatory operations. Able to provide regulatory submission support to other departments with minimal supervision. Establishes and builds collaborative relationships with colleagues and regulatory authorities. Demonstrates flexibility in dealing with change and diversity. Possesses strong critical and logical thinking.