Mark Mannebach Email & Phone Number
Chief Regulatory Officer @ Isosceles Pharmaceuticals
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Mark Mannebach Location
- Naples, FL, US
Mark Mannebach Work
- VP Global Regulatory Affairs @ (November 2008 - January 2017)
- Self-employed
- Chief Regulatory Officer @ (January 2018 - Present)
- Vice President Regulatory Affairs @ (April 2022 - June 2023)
- VP Regulatory Affairs and Quality Asssurance @ Santen, Inc (January 2004 - November 2008)
- Regulatory Affairs Director @ (January 1999 - January 2004)
- Associate Director Regulatory Affairs @ Baxter Healthcare (February 1998 - December 1998)
- Project Leader and CMC Regulatory @ Parke-Davis Warner-Lambert (July 1989 - February 1998)
- Program Manager @ Marion Laboratories (June 1984 - July 1989)
- Sr Research Associate @ Pennwalt (May 1983 - June 1984)
Mark Mannebach Education
- University of Michigan
PhD (Pharmacy Administration)
- University of Detroit
Master's degree (Chemical Engineering)
- Wayne State University
Bachelor of Science (BS) (Pharmacy)
Mark Mannebach Skills
- Regulatory Submissions
- Regulatory Affairs
- CAPA
- Medical Devices
- FDA
- Quality Assurance
- Validation
- Quality System
- Drug Development
- eCTD
- Regulatory Requirements
- Pharmaceutical Industry
- Clinical Development
- GMP
- IND
- 21 CFR Part 11
- V&V
- Regulations
- ISO 13485
- Sop
- ISO 14971
- NDA
- 21 CFR
- CE marking
- GLP
- Change Control
- Biopharmaceuticals
- GCP
- GxP
- FDA GMP
- Design Control
- Technology Transfer
- Pharmacovigilance
- ANDA
- Clinical Trials
- Computer System Validation
- CMC
- Biotechnology
- Pharmaceutics
- Customer Service
- u.s. Food and Drug Administration Fda
- Process Improvement
- Computer System
- Microsoft Office
- Standard Operating Procedure Sop
- Regulatory
- Electronic Common Technical Document Ectd
- u.s. Food and Drug Administration
- Electronic Common Technical Document
- Standard Operating Procedure
Mark Mannebach Summary
- Mark Mannebach, based in Naples, FL, US, is currently a Chief Regulatory Officer at Isosceles Pharmaceuticals. Mark Mannebach brings experience from previous roles at American Regent, Inc., Mallinckrodt Pharmaceuticals, Self-employed and Belite Bio. Mark Mannebach holds a PhD in Pharmacy Administration @ University of Michigan. With a robust skill set that includes Regulatory Submissions, Regulatory Affairs, CAPA, Medical Devices, FDA and more. Mark Mannebach has 4 emails and 4 mobile phone numbers on RocketReach.
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