Fiscal Year

2022

Case Number

A-21291-59605

Case Status

Certified

Received Date

2021-11-09

Decision Date

2022-05-16

Refile

N

Original File Date

2022-01-01 11:28:11

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Fresenius Kabi USA LLC

Employer Name Slug

fresenius-kabi-usa-llc

Employer Address 1

Three Corporate Drive

Employer Address 2

3 S

Employer City

Lake Zurich

Employer City Slug

lake-zurich

Employer State

ILLINOIS

Employer State Slug

illinois

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

60047

Employer Phone

8475502772

Employer Number of Employees

2900

Employer Year Commenced Business

2008

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ioana Zoica

Employer Contact Address 1

Three Corporate Drive

Employer Contact Address 2

3 S

Employer Contact City

Lake Zurich

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60047

Employer Contact Phone

8475502772

Employer Contact Email

ioana.zoica@fresenius-kabi.com

Agent Attorney Name

Jason E Burritt

Agent Attorney Firm Name

Seyfarth Shaw LLP

Agent Attorney Phone

(202) 828-3596

Agent Attorney Address 1

975 F St. N.W.

Agent Attorney Address 2

Agent Attorney City

Washington

Agent Attorney State/Province

DISTRICT OF COLUMBIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

20004

Agent Attorney Email

JBurritt@seyfarth.com

PW Track Number

P10021013010230

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

78437.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-24

PW Expiration Date

2021-08-22

Wage Offer From

93266.91

Wage Offer To

103266.91

Average Salary

98266.91

Wage Unit of Pay

Year

Worksite Address 1

Three Corporate Drive

Worksite Address 2

Worksite City

Lake Zurich

Worksite City Slug

lake-zurich

Worksite State

ILLINOIS

Worksite Postal Code

60047

Job Title

Senior Regulatory Specialist

Job Title Slug

senior-regulatory-specialist

Minimum Education

Bachelor's

Major Field of Study

Chemistry, Biology or Microbiology

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

Please see H.11.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors degree or foreign education equivalent in Chemistry, Biology or Microbiology plus four 4 years of experience in pharmaceutical Regulatory Affairs, including preparation and filing of complete ANDAs, supplements, amendments and annual reports to the Food and Drug Administration. Specific skillsother requirements Must also possess the following 1 Demonstrated expertise DE developing regulatory strategies for resolving complex issues related to new pharmaceutical product development and lifecycle management; 2 DE determining and analyzing regulatory requirements for submissions and change controls for pharmaceutical products to ensure compliance with the CFR, FDAICH guidelines and cGMPs; and 3 DE writing sections of regulatory submissions, responses to agency requests, and annual reports.

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

2021-07-23

SWA Job Order End Date

2021-08-25

Sunday Edition Newspaper

Y

First Newspaper Name

Chicago Tribune

First Advertisement Start Date

2021-08-15

Second Newspaper Ad Name

Chicago Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-22

Employer Website From Date

2022-01-01 11:28:11

Employer Website To Date

2022-01-01 11:28:11

Professional Organization Ad From Date

2022-01-01 11:28:11

Professional Organization Advertisement To Date

2022-01-01 11:28:11

Job Search Website From Date

2021-08-02

Job Search Website To Date

2021-08-16

Employee Referral Program From Date

2022-01-01 11:28:11

Employee Referral Program To Date

2022-01-01 11:28:11

Local Ethnic Paper From Date

2021-08-04

Local Ethnic Paper To Date

2021-08-04

Radio/TV Ad From Date

2021-08-19

Radio/TV Ad To Date

2021-08-19

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

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

MICROBIOLOGY

Foreign Worker Years of Education Completed

2002

Foreign Worker Institution of Education

GURUKULA KANGRI VISHWAVIDYALAYA, HARIDWAR

Foreign Worker Education Institution Address 1

GURUKUL KANGRI VISHWAVIDYALAYA

Foreign Worker Education Institution Address 2

JAGJEETPUR

Foreign Worker Education Institution City

HARIDWAR

Foreign Worker Education Institution State/Province

UTTARAKHAND

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

249404

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Jason E Burritt

Preparer Title

Partner

Preparer Email

jburritt@seyfarth.com

Employer Information Declaration Name

Jason Herrmann

Employer Information Declaration Title

Sr. Manager, Human Resources