Brian Dietz

About Brian Dietz

An experienced leader in Regulatory Operations, Regulatory Labeling with 25 + years experience in the Pharmaceutical Industry.I have held a variety of business functions within Regulatory Affairs and Quality including Regulatory Affairs Labeling, Regulatory/Quality Systems Information Management, Regulatory Project Management, Quality Engineering, Complaints Management and Label Editing.Working with Pharmaceutical Industry leaders such as Abbott, Abbvie, Takeda, Astellas, and Vertex, I have developed experience in Regulatory Labeling Operations leading successful end to end labeling projects from label update and development through implementation on product at manufacturing sites. I have also worked in the update, implementation and management of Quality Systems for pharmaceutical reference information management.I have experience leading diverse teams of professionals through label update projects, CAPA compliance, label process improvements for US, Latin America and the EU and Quality Systems implementation.I have worked with a variety of electronic systems for change control, artwork update and content management activities and have been a people manager for several years and pride myself on the development activities and success of my direct reports.

Experience

1. Senior Regulatory Consultant

   Parexel

   Mar 2020 — Present · US

   Implementation of CCDS updates into US-PIs and US-PI amendments.• Preparation of labeling documents for FDA submission, including the proposed labelling/annotated labelling, SPL, administrative documents.• Coordination and authoring of sections of supplements and submission packages for NDA and ANDA maintenance activities (Annual Reports) and PAERS/PBRERS (ideally to US FDA & EU HAs) to include knowledge of post approval EU regulatory submissions procedures – National, Mutual Recognition and Centralized Procedure.• Regulatory support for Labelling reviews and SPL format drug labeling.• Creation and modification of artworks and mock-ups for US products.• Artwork updates (mainly collaborating with client artwork teams & their manufacturing plants to timely update mock-ups i.e. carton, leaflets etc.)

Education

• Weber State University

  Bachelor of Science (B.S.), Microbiology and Chemistry

  1985 — 1990

Skills

• Microsoft Word
• Powerpoint
• Microsoft Excel
• Capa
• Gmp
• Regulatory Affairs
• Change Control
• Pharmaceutical Industry
• Regulatory Requirements
• Visio