Fiscal Year

2020

Case Number

A-20095-39203

Case Status

Certified

Received Date

2020-04-14

Decision Date

2020-09-02

Refile

N

Original File Date

2020-01-01 19:58:25

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

GL SCIENTIFIC INC.

Employer Name Slug

gl-scientific-inc

Employer Address 1

25 INDEPENDENCE BLVD

Employer Address 2

SUITE 404

Employer City

WARREN

Employer City Slug

warren

Employer State

NEW JERSEY SOMERSET

Employer State Slug

new-jersey-somerset

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7059

Employer Phone

2015799344

Employer Number of Employees

29

Employer Year Commenced Business

2017

NAICS Code

54169

FW Ownership Interest

N

Employer Contact Name

Joanne C Reilly

Employer Contact Address 1

25 Independence Blvd

Employer Contact Address 2

Suite 404

Employer Contact City

Warren

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7059

Employer Contact Phone

2015799344

Employer Contact Email

[email protected]

Agent Attorney Name

Jenny Schrager

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

[email protected]

PW Track Number

P10019240048313

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

98322.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-12-31

PW Expiration Date

2020-06-30

Wage Offer From

98322.00

Wage Offer To

0.00

Average Salary

98322.00

Wage Unit of Pay

Year

Worksite Address 1

25 Independence Blvd.

Worksite Address 2

Suite 404

Worksite City

Warren

Worksite City Slug

warren

Worksite State

NEW JERSEY

Worksite Postal Code

7059

Job Title

Regulatory Affairs Manager, CMC

Job Title Slug

regulatory-affairs-manager-cmc

Minimum Education

Bachelor's

Major Field of Study

Reg.Affairs,Pharma.Sci,Biopharma,Chem.Engg,Bio,Microbio,Virology,Molecular Bio,Biochem,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

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

84

Accept Alternative Job Title

Job offered or related occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Position requires a Bachelors degree, or foreign equivalent, in Regulatory Affairs, Pharmaceutical Science, Biopharmaceutical, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry, or a related field and seven 7 years of progressively responsible postBachelors degree experience in the job offered or related occupation. Alternatively, the employer will accept a Masters degree, or foreign equivalent, in Regulatory Affairs, Pharmaceutical Science, Biopharmaceutical, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry, or a related field and five 5 years of experience in the job offered or related occupation. Position also requires 5 years of experience with FDA, EMA, and ICH regulationsguidance and requirements and experience applying these requirements to develop regulatory submissions; 5 years of experience providing strategic regulatory guidance to global drug development, registration, and postmarket support teams; 5 years of experience reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data; 5 years of experience with Regulatory Submissions, including reviewing and authoring CMC sections; and 3 years of experience in Pharmaceutical industry in drug development with a focus on the regulatory CMC processes.

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

2020-01-28

SWA Job Order End Date

2020-02-27

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2020-02-02

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-02-09

Employer Website From Date

2020-01-01 19:58:25

Employer Website To Date

2020-01-01 19:58:25

Professional Organization Ad From Date

2020-01-01 19:58:25

Professional Organization Advertisement To Date

2020-01-01 19:58:25

Job Search Website From Date

2020-02-03

Job Search Website To Date

2020-03-02

Employee Referral Program From Date

2020-01-01 19:58:25

Employee Referral Program To Date

2020-01-01 19:58:25

Local Ethnic Paper From Date

2020-02-05

Local Ethnic Paper To Date

2020-02-05

Radio/TV Ad From Date

2020-02-08

Radio/TV Ad To Date

2020-02-08

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

DRUG REGULATORY AFFAIRS ALSO EARNED AN MBA IN 2014

Foreign Worker Years of Education Completed

2011

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY PLAZA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Jenny S Schrager

Preparer Title

Partner

Preparer Email

[email protected]

Employer Information Declaration Name

Joanne Reilly

Employer Information Declaration Title

VP, HR