Paul Rohlfing
- Role
- Executive Director, Global Cmc, Regulatory Science at Pfizer
- Location
- Greensboro, NC, US
- LinkedIn followers
- 500 followers
About Paul Rohlfing
Achievement of exceptional results in managing both technical and operations…
Experience
Executive Director, Global Cmc, Regulatory Science
Oct 2017 — Present
Lead the Global Regulatory Science Chemistry, Manufacturing, and Controls (CMC) organization supporting clinical development, licensure and post-approval management of Pfizer\'s vaccine portfolio. Significantly expanded group\'s capability to concurrently manage multiple late-stage development programs through initial registration, licensure, and launch, while also providing high level of support for maintenance of dossiers for commercial products. These included multiple transfers of production operations for six products. Notable achievements include leading global licensing of the 20-valent S. pneumo conjugate vaccine while also accountable for CMC activities in support of an accelerated development, authorization, and licensure of the first mRNA COVID-19 vaccine and follow-on variant vaccines.
Skills
- Pharmaceutical Industry
- Gmp
- Technology Transfer
- Regulatory Affairs
- Process Simulation
- Cross-Functional Team Leadership
- Chemistry
- Quality System
- Validation
- Fda
- Biotechnology
- Vaccines
- Six Sigma
- Drug Development
- Manufacturing
- Formulation
- Regulatory Requirements
- Change Control
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