Michael Vandi

Senior Manager, Global Regulatory Affairs

Michael Vandi is a skilled expert, that works in Alexion Pharmaceuticals, Inc main office of which is in 499. on the position of Senior Manager, Global Regulatory Affairs since 2020. Michael Vandi has earned professional experience in more than 12 positions at different companies. Michael Vandi went to the Northeastern University and got education from 2013 to 2016. This expert has such professional qualifications as Regulatory Affairs Certification (Us), Regulatory Affairs Professionals Society (Raps), and Regulatory Affairs Certification (Rac) - United States. Cambridge, Massachusetts is the area, where this person was known to settle. This person's e-mail and phone are easily accessed through this website by request.
Name variants:
Mikael Vandi, Mychael Vandi, Mike Vandi, Mikey Vandi, Mick Vandi, Mickey Vandi, Micky Vandi, Michl Vandi, Mischa Vandi
Last updated Jun 04, 2024

Contact Information

Last Update
Jul 8, 2022
Email
mv**@gmail.com
Location
Cambridge, MA

Workplace

Alexion Pharmaceuticals, Inc.
Senior Manager, Global Regulatory Affairs

Industry

Biotechnology

Work History

Senior Manager, Global Regulatory Affairs

121 Seaport Blvd, Boston, MA 02210
from Mar 2020

Regulatory Cmc Submissions Manager at Takeda

from Jan 2019

Regulatory Cmc Submissions Lead

Sep 2018 — Jan 2019

Senior Quality Assurance Specialist

Apr 2017 — Sep 2018

Quality Engineer Consultant

DPS delivers Full Service Engineering with a ‘client first' mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction...
Mar 2016 — Apr 2017

Compliance Specialist Ii, Cmc

60 Binney St, Cambridge, MA 02142
Compliance Specialist II, QA
Jul 2014 — Oct 2015

Quality Systems Engineer

50 Binney St, Cambridge, MA 02142
Nov 2012 — Jul 2014

Quality Assurance Specialist

41 Seyon St, Waltham, MA 02453
Jun 2012 — Nov 2012

Quality Assurance Associate

15 Wiggins Ave, Bedford, MA 01730
2011 — 2012

Tutor

Lowell, MA
Sep 2009 — Mar 2011

Assistant Manager

Hamilton, MA
May 2002 — Aug 2010

Quality Assurance Officer

2000 — Jul 2011

Education

2013 — 2016

Bachelor of Science in Biology

Lowell, MA
from Dec 2010

Occupations

Executive
Senior Manager
Scientist
Biotechnology Professional
Operations Manager
Biologist
Biological Scientist

Skills

Biotechnology
Quality System
Gmp
Quality Assurance
Glp
Validation
Fda
Pharmaceutical Industry
Sop
Change Control
21 Cfr Part 11
Life Sciences
Capa
Biopharmaceuticals
Regulatory Affairs
Good Laboratory Practice
Clinical Trials
Gcp
Medical Devices
Sops
Cell Culture
Lifesciences
Standard Operating Procedure
Regulatory Submissions
Technology Transfer
Good Clinical Practice
Regulatory Documentation
New Drug Application
Ind
Bla
Common Technical Document
Cta
Electronic Common Technical Document
Regulatory Compliance
Regulatory Requirements
Nda
Cmc Regulatory Affairs
Drug Development
Regulatory Filings
Clinical Development
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