Executive: Director Head of Regulatory Operations - San Diego, California - (San Diego, CA)

Provides leadership in creating, overseeing, trouble-shooting, training, and managing electronic publications and filing processes for global regulatory submissions. Works with Regulatory Affairs and Technical Function authors as well as Regulatory Agencies to ensure that documents and submissions comply with regulatory and company guidance / specifications. Main responsibilities: Leadership role in the development of compliant electronic systems; plans, prepares, and tracks regulatory electronic documents and submissions ensuring conformance with regulatory qualifications, guidelines, internal standards and timelines. Leads support for worldwide regulatory electronic submissions ensuring submission qualifications are met. Leads in the development of processes for departmental Work Instruction Documents outlining the generation of electronic submission-ready documents.