Act as Regulatory Lead for cross-departmental submissions for oncology pharmaceutical drugs during different phases of development by providing strategy input and authoring of regulatory documents.

Responsible for FDA submissions on Computed Tomography and Radiation Oncology products. Review and approve marketing materials and price-book information.

o Serve as link between client and production staff.o Process incoming orders and deliver completed projects.o Anticipate client needs and address concerns.o Answer client questions in a professional and complete manner.o Publishing and QC of project files.o Development of SOP and ownership of wiki pages

o Responsible for obtaining and dissemination of internal and government documents to regional managers to support global pharmaceutical filings.o Use Microsoft Sharepoint to update department documents.o Maintain tracking sheets of document progress.

o Experience with Structured Product Labeling.o Experience with the FDA SPL Implementation Procedures and related regulations.o Experience with different types of Structured Product Labeling submissions: Establishment Registrations Labeler Code Requests. Drug Listings:o Prescriptiono Over-the-Countero Homeopathico Animal Healtho Experience with Customer Service: Processing incoming orders Anticipating client needs Answering client questions regarding regulations Acting as main contact between production team and client

o Experience with: CMC documents Clinical and Nonclinical study reports Case Report Forms Summary Documentso Experience in eCTD and hybrid submissions.o Experience in paper submissions.o Experience in training new employees on standards and procedures.o Duties included: Following Standard Operating Procedures in all aspects of job performance. Multi-tasking when working on multiple submissions. Publishing and QCing case report forms, clinical and nonclinical study reports, datasets, and other regulatory documents in accordance with ICH guidelines. Resolving issues found by team members and by client. Assigning tasks to team members. Managing project timelines. Preparing administrative documents – meeting minutes, agendas, emails. Creation of XML backbone for eCTD submissions. Acting as a liaison between client and Octagon.o On-site publishing support at AstraZeneca. Work completed on Case Report Forms and Clinical Study Reports.