Monique Meigio

Senior Manager, Global Regulatory Affairs

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Monique Meigio

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Contact Information

Last Update
Jul 11, 2022
Email
mm**@amicusrx.com, mm**@amicustherapeutics.com
Location
West Chester, PA

Workplace

Amicus Therapeutics
Senior Manager, Global Regulatory Affairs

Industry

Biotechnology

Work History

Senior Manager, Global Regulatory Affairs

1 Cedar Brk Dr, Cranbury, NJ
from Jan 2020

Us Regulatory Strategy Specialist Neuroscience and Gi

Prepare, compile, review/QC regulatory documents necessary for lifecycle management including IND, BLA, NDA, amendments/supplements, annual reports, safety reports, and general corresponden...
Mar 2014 — Dec 2015

Regulatory Affairs Associate

Execute and coordinate successful submissions to Health Canada, EMA, and the FDA e.g., annual reports, safety reports, protocol amendments, promotional regulatory affairs submissions, and p...
Mar 2013 — Mar 2014

Regulatory Affairs Intern

☑ Executed regulatory submissions to Global Health Authorities ☑ Reviewed advertising and promotional pieces ☑ Conducted regulatory intelligence and policy activities
May 2011 — Dec 2012

Education

Jan 1, 2013 — 2015

Occupations

Executive
Senior Manager
Bachelor of Liberal Arts
Doctor
Ophthalmologist
Neuropsychiatrist
Operations Manager
Physician
Neurological Specialist
Neurologist

Skills

Regulatory Submissions
Regulatory Affairs
Ectd
Pharmaceutical Industry
Regulatory Requirements
Ind
Fda
Clinical Trials
Sop
Drug Development
Nda
Glp
Pharmacovigilance
Clinical Development
21 Cfr Part 11
Gcp
Ctms
Cro
Ich Gcp
Therapeutic Areas
Clinical Trial Management System
Standard Operating Procedure
New Drug Application
U.s. Food and Drug Administration
Cro Management
Good Clinical Practice

FAQs about Monique Meigio

What's the profession of Monique Meigio?

This professional's job is Senior Manager, Global Regulatory Affairs

What are the main profession of Monique?

These person's professions are Executive and Senior Manager

Where does Monique Meigio currently live?

West Chester, Pennsylvania is the place where Monique Meigio lives

What is the expert's email?

The expert's email is mm**@amicusrx.com and mm**@amicustherapeutics.com.

Where did Monique Meigio work?

The expert worked at Amicus Therapeutics, Shire.

Where has Monique Meigio studied?

Monique studied at the Johns Hopkins University from 2013 to 2015.

Are there any industries, that Monique Meigio works in?

This person works in Pharmaceuticals industry.

What are the skills of Monique Meigio?

Monique Meigio has such skills as Regulatory Submissions, Regulatory Affairs, Ectd, Pharmaceutical Industry, Regulatory Requirements, Ind, Fda, Clinical Trials, Sop, Drug Development, Nda, and Glp.
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