Fiscal Year

2021

Case Number

A-20182-71543

Case Status

Certified-Expired

Received Date

2020-07-15

Decision Date

2021-02-24

Refile

N

Original File Date

2021-01-01 09:03:11

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ALEXION PHARMACEUTICALS, INC.

Employer Name Slug

alexion-pharmaceuticals-inc

Employer Address 1

121 SEAPORT BLVD

Employer Address 2

Employer City

BOSTON

Employer City Slug

boston

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2210

Employer Phone

4752302596

Employer Number of Employees

1653

Employer Year Commenced Business

1992

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Felicia Robichaud

Employer Contact Address 1

100 College St

Employer Contact Address 2

Employer Contact City

New Haven

Employer Contact State/Province

CONNECTICUT

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

6510

Employer Contact Phone

4752302596

Employer Contact Email

felicia.robichaud@alexion.com

Agent Attorney Name

Nadir Ismayil

Agent Attorney Firm Name

Ismayil LLC

Agent Attorney Phone

2408598639

Agent Attorney Address 1

6710A Rockledge Dr

Agent Attorney Address 2

Ste 400

Agent Attorney City

Bethesda

Agent Attorney State/Province

MARYLAND

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

20817

Agent Attorney Email

nadir@ismayillaw.com

PW Track Number

P10019221037703

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

159744.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-12-09

PW Expiration Date

2020-06-30

Wage Offer From

159744.00

Wage Offer To

0.00

Average Salary

159744.00

Wage Unit of Pay

Year

Worksite Address 1

121 Seaport Blvd

Worksite Address 2

Worksite City

Boston

Worksite City Slug

boston

Worksite State

MASSACHUSETTS

Worksite Postal Code

2210

Job Title

Manager, Global Regulatory Operations

Job Title Slug

manager-global-regulatory-operations

Minimum Education

Master's

Major Field of Study

regulatory affairs, regulatory compliance, or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

a pharmaceutical regulatory compliance occupation

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

3 years of progressive experience in a pharmaceutical regulatory compliance occupation. In addition, experience must includebr 3 years of experience working with regulatory operations and publishing.br 3 years of experience working with publishing and compiling CTDeCTD submissions for USA and European Union filings.br 3 years of experience working with implementation and utilization of electronic submission gateways ESGs.br 3 years of experience working with eCTD validation, publishing, and QC tools.br 3 years of experience working with Microsoft Office Suite, Adobe Acrobat, Adobe PlugIns such as ISIToolbox, electronic document management systems, eCTD publishing tools, and eCTD validation and viewing tools.br 3 years of experience working with CDISC compliant datasets and CRFs and other regional requirements.br Up to 5 of domestic and international travel.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2020-02-04

SWA Job Order End Date

2020-03-05

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2020-03-08

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-03-15

Employer Website From Date

2021-01-01 09:03:11

Employer Website To Date

2021-01-01 09:03:11

Professional Organization Ad From Date

2021-01-01 09:03:11

Professional Organization Advertisement To Date

2021-01-01 09:03:11

Job Search Website From Date

2020-03-10

Job Search Website To Date

2020-03-17

Employee Referral Program From Date

2021-01-01 09:03:11

Employee Referral Program To Date

2021-01-01 09:03:11

Local Ethnic Paper From Date

2020-03-13

Local Ethnic Paper To Date

2020-03-13

Radio/TV Ad From Date

2020-03-12

Radio/TV Ad To Date

2020-03-13

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Nadir Ismayil

Preparer Title

Attorney

Preparer Email

nadir@ismayillaw.com

Employer Information Declaration Name

Felicia Robichaud

Employer Information Declaration Title

Paralegal, Employment and Litigation