Fiscal Year

2020

Case Number

A-19203-33859

Case Status

Certified

Received Date

2019-11-22

Decision Date

2020-04-14

Refile

N

Original File Date

2020-01-01 07:40:16

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BAYER U.S. LLC

Employer Name Slug

bayer-us-llc

Employer Address 1

100 BAYER BOULEVARD

Employer Address 2

Employer City

WHIPPANY

Employer City Slug

whippany

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7981

Employer Phone

412-777-2375

Employer Number of Employees

15000

Employer Year Commenced Business

1884

NAICS Code

325411

FW Ownership Interest

N

Employer Contact Name

Mary Ellen Mahoney

Employer Contact Address 1

100 Bayer Road

Employer Contact Address 2

Employer Contact City

Pittsburgh

Employer Contact State/Province

PENNSYLVANIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

15205

Employer Contact Phone

412-777-2375

Employer Contact Email

mary-ellen.mahoney@bayer.com

Agent Attorney Name

Alexander R Castrodale

Agent Attorney Firm Name

Cohen Grigsby, P.C.

Agent Attorney Phone

4122974712

Agent Attorney Address 1

625 Liberty Avenue, 5th Floor

Agent Attorney Address 2

Agent Attorney City

Pittsburgh

Agent Attorney State/Province

PENNSYLVANIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

15222

Agent Attorney Email

acastrodale@cohenlaw.com

PW Track Number

P10018311781637

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists 131041.07

PW Skill Level

Level IV

PW Wage

100630.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-09

PW Expiration Date

2019-08-07

Wage Offer From

119025.00

Wage Offer To

0.00

Average Salary

119025.00

Wage Unit of Pay

Year

Worksite Address 1

100 Bayer Boulevard

Worksite Address 2

Worksite City

Whippany

Worksite City Slug

whippany

Worksite State

NEW JERSEY

Worksite Postal Code

7981

Job Title

Assistant Director, Regulatory Chemistry Manufacturing and Control

Job Title Slug

assistant-director-regulatory-chemistry-manufacturing-and-control

Minimum Education

Master's

Major Field of Study

Regulatory Science or 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

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

48

Accept Alternative Job Title

Related role in the pharmaceutical industry

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Experience must include three 3 years in a Regulatory Affairs role.br br Must have any experience with or knowledge of i U.S. IND, NDABLA submission process and amendments; ii developing regulatory strategies for small molecules, biologics, including gene therapy products in support of new INDCTA andor NDABLA applications; iii interacting with the FDA and international regulatory bodies inclusive of pre and postapproval regulatory matters; iv pharmaceutical manufacturing andor quality control; v INDCTA, MAANDA andor BLA drug development, inclusive of applicable health authority and ICH requirements; vi FDA postapproval change requirements 21 CFR 314.70; and vii antibody compounds and gene therapy products regulations to support INDCTA and NDABLAMAA applications.br br Experience can be concurrent.br br Note Because there is no experience required in H.6, the Kellogg language is not required.

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

2019-05-30

SWA Job Order End Date

2019-07-01

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2019-06-09

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-16

Employer Website From Date

2019-05-28

Employer Website To Date

2019-08-08

Professional Organization Ad From Date

2020-01-01 07:40:16

Professional Organization Advertisement To Date

2020-01-01 07:40:16

Job Search Website From Date

2019-06-10

Job Search Website To Date

2019-06-21

Employee Referral Program From Date

2020-01-01 07:40:16

Employee Referral Program To Date

2020-01-01 07:40:16

Local Ethnic Paper From Date

2019-06-12

Local Ethnic Paper To Date

2019-06-12

Radio/TV Ad From Date

2020-01-01 07:40:16

Radio/TV Ad To Date

2020-01-01 07:40:16

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 SCIENCE

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

3551 TROUSDALE PARKWAY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90007

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Alexander R Castrodale

Preparer Title

Attorney

Preparer Email

acastrodale@cohenlaw.com

Employer Information Declaration Name

Mary Ellen Mahoney

Employer Information Declaration Title

HR Advisor