1998 -1998 Associate Director Regulatory Affairs @ Baxter Healthcare
1989 -1998 Project Leader and CMC Regulatory @ Parke-Davis Warner-Lambert
1984 -1989 Program Manager @ Marion Laboratories
1983 -1984 Sr Research Associate @ Pennwalt
Mark Mannebach Education
University of Detroit
Master's degree (Chemical Engineering)
University of Michigan
PhD (Pharmacy Administration)
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 Master's degree in Chemical Engineering @ University of Detroit. 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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