Fiscal Year

2022

Case Number

A-21235-35010

Case Status

Certified

Received Date

2022-01-10

Decision Date

2022-08-29

Refile

N

Original File Date

2022-01-01 06:33:20

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTELLAS

Employer Name Slug

astellas

Employer Address 1

DBA ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.

Employer Address 2

1 ASTELLAS WAY

Employer City

NORTHBROOK

Employer City Slug

northbrook

Employer State

ILLINOIS

Employer State Slug

illinois

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

60062

Employer Phone

224-205-8800

Employer Number of Employees

793

Employer Year Commenced Business

2005

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Pâmela Caballero

Employer Contact Address 1

Astellas Pharma Global Development, Inc.

Employer Contact Address 2

1 Astellas Way

Employer Contact City

Northbrook

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60062

Employer Contact Phone

847-970-2573

Employer Contact Email

pamela.caballero@astellas.com

Agent Attorney Name

Poonam Gupta

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

(469) 290-9325

Agent Attorney Address 1

11 Times Square

Agent Attorney Address 2

11th Floor

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10036

Agent Attorney Email

poonam.gupta@BAL.com

PW Track Number

P10020345951676

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialist

PW Skill Level

Level IV

PW Wage

92997.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-04-22

PW Expiration Date

2021-07-21

Wage Offer From

110000.00

Wage Offer To

120000.00

Average Salary

115000.00

Wage Unit of Pay

Year

Worksite Address 1

1 Astellas Way

Worksite Address 2

Worksite City

Northbrook

Worksite City Slug

northbrook

Worksite State

ILLINOIS

Worksite Postal Code

60062

Job Title

Senior Regulatory Publishing Submissions Associate

Job Title Slug

senior-regulatory-publishing-submissions-associate

Minimum Education

Master's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.14

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

4

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Minimum Requirements Masters degree or the foreign equivalent in Chemistry, Pharmaceutical Science, or related field in LifeHealth Science, and 24 months in the job offered, or as a Regulatory Submissions Specialist or related position.br br Alternate Requirements Bachelors degree or the foreign equivalent in Chemistry, Pharmaceutical Science, or related field in LifeHealth Science, and 48 months in the job offered, or as a Regulatory Submissions Specialist or related position.br br Special Skills Two 2 years of experience in regulatory affairs in the pharmaceutical industry or in a clinical setting, and involving two 2 years of experience in all of the following a Ensuring document submission contents adhere to U.S. Food and Drug Administration FDA, International Council for Harmonization ICH, and internal standards, through interpretation of regulations and guidance documents; b Preparing, submitting, distributing and archiving FDA submissions, including New Drug Applications NDAs, Biologic License Applications BLAs, and Investigational New Drugs INDs; c Supporting Marketing Authorization Applications MAAs submitted to European Medicines Agency EMA and New Drug Submissions NDS to Health Canada using Veeva Vault including PromoMats, RIM and eTMF, Adobe Acrobat, ISI Toolbox, MSOffice Product Suite 2020, Documentum, SAS Viewer, eCTDXPress and DocuBridge; and d Providing oversight to facilitate processing and publishing Chemistry Manufacturing and Controls CMC and related documents, clinical study reports, preclinical reports, annual reports, aggregate reports, and original INDNDA dossiers ensuring final documents meet company specifications and FDA guidelines. Experience may be concurrent.br br Position requires less than 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

2021-07-21

SWA Job Order End Date

2021-08-23

Sunday Edition Newspaper

Y

First Newspaper Name

Chicago Tribune

First Advertisement Start Date

2021-11-28

Second Newspaper Ad Name

Chicago Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-05

Employer Website From Date

2022-01-01 06:33:20

Employer Website To Date

2022-01-01 06:33:20

Professional Organization Ad From Date

2022-01-01 06:33:20

Professional Organization Advertisement To Date

2022-01-01 06:33:20

Job Search Website From Date

2021-07-16

Job Search Website To Date

2021-07-30

Employee Referral Program From Date

2022-01-01 06:33:20

Employee Referral Program To Date

2022-01-01 06:33:20

Local Ethnic Paper From Date

2021-07-21

Local Ethnic Paper To Date

2021-07-21

Radio/TV Ad From Date

2021-07-20

Radio/TV Ad To Date

2021-07-21

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

CHEMISTRY

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

WESTERN ILLINOIS UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY CIR.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MACOMB

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

61455

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Poonam Gupta

Preparer Title

Senior Counsel

Preparer Email

poonam.gupta@BAL.com

Employer Information Declaration Name

Pmela Caballero

Employer Information Declaration Title

Talent Acquisition, HR