Paul Dawidczyk
- Role
- Vice President, Regulatory Affairs Cmc at Lundbeck
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
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About Paul Dawidczyk
Experienced Regulatory Affairs Professional with knowledge regarding drugs, biologics…
Experience
Vice President, Regulatory Affairs Cmc
Oct 2022 — Present
Education
University of Massachusetts Amherst
BS, Biochemistry
Skills
- Change Control
- Iso 13485
- Cmc Regulatory Affairs
- Regulatory Submissions
- Monoclonal Antibodies
- Ind
- Biopharmaceuticals
- Biotechnology
- Capa
- Cmc
- Quality System
- Design Control
- Quality Control
- Fda
- V
- Cgmp
- Medical Devices
- Biologics
- Gmp
- Pharmaceutical Industry
- Trackwise
- Corrective and Preventive Action (Capa)
- Regulatory Affairs
- Assay Development
- Purification
- U.s. Food and Drug Administration (Fda)
- Pma
- Iso 14971
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