Marcus Juliano Email & Phone Number
Vice President of Regulatory Affairs @ XGen Pharmaceuticals DJB
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Marcus Juliano Location
- Horseheads, NY, US
Marcus Juliano Work
- Vice President of Regulatory Affairs @ (October 2019 - Present)
- Senior Director, Regulatory Affairs @ (June 2015 - October 2019)
- Regulatory Affairs Manager @ (January 2014 - June 2015)
- Quality Operations Manager @ (April 2013 - January 2014)
- Vice President, Regulatory Affairs and Quality @ (January 2008 - July 2012)
- Sr. Regulatory Affairs Specialist @ (March 2007 - January 2008)
- Regulatory Affairs Specialist @ (November 2002 - March 2007)
- Quality Engineer, Manufacturing Quality Assurance @ (February 2001 - November 2002)
- Team Leader, Incoming Quality Inspection @ (July 1999 - February 2001)
- Quality Control Microbiologist @ (June 1997 - July 1999)
- Quality Control Microbiology Technician @ (December 1994 - June 1997)
- Research and Development - Co-Op Student and Internship @ (January 1994 - May 1994)
Marcus Juliano Education
- University of South Florida
MBA (Management, Marketing, International Business)
2002-2006 - University of South Florida
BS (Biology)
1991-1996
Marcus Juliano Skills
- DMF
- New Drug Application (NDA)
- Advisory comm
- Clinical Trials
- Pre-clinical Studies
- Module 3
- State Licensing
- Regulatory Labeling
- Regulatory Compliance
- 505b2
- Regulatory Affairs
- FDA
- GMP
- Regulatory Submissions
- Regulatory Requirements
- Pharmaceutical Industry
- Quality System
- CAPA
- Change Control
- Standard Operating Procedure (SOP)
- Quality Auditing
- Pharmacovigilance
- Microbiology
- Medical Devices
- Continuous Improvement
- Leadership
- Cross-functional Team Leadership
- Management
- IND
- NDA
- ANDA
- CTD
- eCTD
- CMC
- Regulatory Filings
- cGMP
- Quality Operations
- Quality by Design
- Pharmaceutical Manufacturing
- Compliance
- Complaint Management
- Aseptic Processing
- SOP development
- USP
- Small Molecules
- Fast Track
- Orphan Drugs
- Generic Drugs
- Regulatory Operations
- CMC Regulatory Affairs
- Sterilization
- Regulations
- 21 CFR
- 510K
- 21 CFR Part 11
- Validation
- Trackwise
- Process Improvement
- Cosmeceuticals
- Quality Assurance
- Pharmaceutics
- Manufacturing
- Stability
- FDA GMP
- 21Cfr 111
- Project Management
- Quality Control
- Food Supplements
- Sop
- HACCP
- Electronic Submissions
- Abbreviated New Drug Application Anda
- Pharmaceutical
- Standard Operating Procedure Sop
- Standard Operating Procedure
- Abbreviated New Drug Application
- Cross Functional Team Leadership
Marcus Juliano Summary
- Marcus Juliano, based in Horseheads, NY, US, is currently a Vice President of Regulatory Affairs at XGen Pharmaceuticals DJB. Marcus Juliano brings experience from previous roles at KemPharm, Inc., Romark Laboratories, L.C., Celmark International and Nephron Pharmaceuticals. Marcus Juliano holds a 2002 - 2006 MBA in Management, Marketing, International Business @ University of South Florida. With a robust skill set that includes DMF, New Drug Application (NDA), Advisory comm, Clinical Trials, Pre-clinical Studies and more. Marcus Juliano has 3 emails and 6 mobile phone numbers on RocketReach.
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