Vlad Liberman
- Role
- Senior Director, Regulatory Affairs, Cmc at AbbVie
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Vlad Liberman
Analytical and strategic business leader with experience leading biological and small…
Experience
Senior Director, Regulatory Affairs, Cmc
Jun 2018 — Present
Lead an organization of 25+ with accountability for development pipeline and commercial assets. Lead regulatory strategy, providing technical direction and all aspects of regulatory submissions from FIH to NDA/BLA, global market expansions, and lifecycle management activities, supporting R&D, Operations, and Commercial organizations. Assumed responsibility for the entire legacy Allergan portfolio of products as part of Allergan/AbbVie merger. Provide regulatory direction and sign off to control strategy review board and global specification approvals for all products in development through commercialization. Represent regulatory on regulatory starting material, mutagenicity/genetic toxicology and nitrosamine core teams for all pipeline and commercial products
Skills
- International Regulatory
- Impd
- Regulatory
- Cmc
- Clinical Development
- Hplc
- Big Pharma
- Fda
- Regulatory Affairs
- Chemistry
- Regulatory Filings
- Nda
- Chromatography
- Dissolution
- Regulatory Strategy
- Formulation
- Quality
- Ind
- Small Molecule
- Pharmaceutical Industry
- Regulatory Submissions
- Regulations
- Ectd
- Pharmaceuticals
- Drug Development
- Capa
- Qos
- Sop
- Quality by Design
- Lc-Ms
- Analytical Chemistry
- R&D
- Biotechnology
- Validation
- Biopharmaceuticals
- Small Molecules
- Mass Spectrometry
- Pharmaceutics
- Life Sciences
- Biotech
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