Fiscal Year

2021

Case Number

A-20093-38568

Case Status

Certified-Expired

Received Date

2020-05-01

Decision Date

2020-10-09

Refile

N

Original File Date

2021-01-01 08:45:24

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

CURIUM US LLC

Employer Name Slug

curium-us-llc

Employer Address 1

2703 WAGNER PLACE

Employer Address 2

Employer City

MARYLAND HEIGHTS

Employer City Slug

maryland-heights

Employer State

MISSOURI

Employer State Slug

missouri

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

63043

Employer Phone

3145953789

Employer Number of Employees

363

Employer Year Commenced Business

2014

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Michael Gruen

Employer Contact Address 1

2703 Wagner Place

Employer Contact Address 2

Employer Contact City

Maryland Heights

Employer Contact State/Province

MISSOURI

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

63043

Employer Contact Phone

3145953789

Employer Contact Email

michael.gruen@curiumpharma.com

Agent Attorney Name

Kelli J Meilink

Agent Attorney Firm Name

Husch Blackwell LLP

Agent Attorney Phone

8169838309

Agent Attorney Address 1

4801 Main Street

Agent Attorney Address 2

Suite 1000

Agent Attorney City

Kansas City

Agent Attorney State/Province

MISSOURI

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

64112

Agent Attorney Email

kelli.meilink@huschblackwell.com

PW Track Number

P10019294097717

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

54205.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-02-19

PW Expiration Date

2020-06-30

Wage Offer From

85000.00

Wage Offer To

0.00

Average Salary

85000.00

Wage Unit of Pay

Year

Worksite Address 1

2703 Wagner Place

Worksite Address 2

Worksite City

Maryland Heights

Worksite City Slug

maryland-heights

Worksite State

MISSOURI

Worksite Postal Code

63043

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Bachelor's

Major Field of Study

Chem., Pharm., Bio., Reg. Affairs or related

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

36

Accept Alternative Job Title

any pharmaceutical regulatory affairs position

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Bachelors degree in Chemistry, Pharmacy, Biology, Regulatory Affairs, or related degree plus three years of experience working in Pharmaceutical Regulatory Affairs. Three years of experience preparing Food and Drug Administration submissions, including Abbreviated New Drug Applications ANDA, New Drug Applications NDA, and Drug Master Files, including reviewing work of others for technical adequacy and interacting with reviewers at the agency. Demonstrated knowledge of Chemistry, Manufacturing, and Controls CMC documentation. Three years of experience with publishing software and eCTD publishing process. Demonstrated understanding of regulatory application processes and the basis of regulations. Demonstrated knowledge of federal acts and regulations affecting proposed and marketed products.

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

2020-01-22

SWA Job Order End Date

2020-02-24

Sunday Edition Newspaper

Y

First Newspaper Name

St. Louis PostDispatch

First Advertisement Start Date

2020-01-12

Second Newspaper Ad Name

St. Louis PostDispatch

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-01-19

Employer Website From Date

2019-12-18

Employer Website To Date

2020-01-22

Professional Organization Ad From Date

2021-01-01 08:45:24

Professional Organization Advertisement To Date

2021-01-01 08:45:24

Job Search Website From Date

2019-12-16

Job Search Website To Date

2020-01-13

Employee Referral Program From Date

2021-01-01 08:45:24

Employee Referral Program To Date

2021-01-01 08:45:24

Local Ethnic Paper From Date

2021-01-01 08:45:24

Local Ethnic Paper To Date

2021-01-01 08:45:24

Radio/TV Ad From Date

2021-01-01 08:45:24

Radio/TV Ad To Date

2021-01-01 08:45:24

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

Foreign Worker Years of Education Completed

2011

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

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

Kelli J Meilink

Preparer Title

Attorney

Preparer Email

kelli.meilink@huschblackwell.com

Employer Information Declaration Name

Robert Budenholzer

Employer Information Declaration Title

Vice President General Counsel, North America