Fiscal Year

2020

Case Number

A-19196-30735

Case Status

Certified-Expired

Received Date

2019-10-31

Decision Date

2020-04-01

Refile

N

Original File Date

2020-01-01 07:36:16

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

InvaGen Pharmaceuticals, Inc.

Employer Name Slug

invagen-pharmaceuticals-inc

Employer Address 1

7 Oser Avenue

Employer Address 2

Employer City

Hauppauge

Employer City Slug

hauppauge

Employer State

NEW YORK

Employer State Slug

new-york

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

11788

Employer Phone

6316501176

Employer Number of Employees

650

Employer Year Commenced Business

2003

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

DeVaughn Stephens

Employer Contact Address 1

550 S. Research Place

Employer Contact Address 2

Human Resources Department

Employer Contact City

Central Islip

Employer Contact State/Province

NEW YORK

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

11722

Employer Contact Phone

6316501176 557

Employer Contact Email

devaughn.stephens@cipla.com

Agent Attorney Name

David Nachman

Agent Attorney Firm Name

NPZ Law Group, P.C.

Agent Attorney Phone

2016700006

Agent Attorney Address 1

Visaserve Plaza

Agent Attorney Address 2

487 Goffle Road , NJ

Agent Attorney City

Ridgewood

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7450

Agent Attorney Email

David_nachman@visaserve.com

PW Track Number

P10018340883377

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

59800.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-04-15

PW Expiration Date

2019-07-14

Wage Offer From

64000.00

Wage Offer To

0.00

Average Salary

64000.00

Wage Unit of Pay

Year

Worksite Address 1

7 Oser Avenue

Worksite Address 2

Worksite City

Hauppauge

Worksite City Slug

hauppauge

Worksite State

NEW YORK

Worksite Postal Code

11788

Job Title

Regulatory Affairs Specialist

Job Title Slug

regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs Quality Assurance QA

Required Training

N

Required Experience

Y

Required Experience Months

24

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

N

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must have a Masters degree in Regulatory Affairs and Quality Assurance. Applicant must have at least 2 years of experience in regulatory affairs within a generic pharmaceutical environment. Applicant must have handson experience with preparing and reviewing and as filings and Other regulatory submissions amendments, supplements, annual reports and additional documentation with USFDA. Must be proficient in Applicable computer and database applications including MS Word, MS Excel, PDF, ECTD submissions software, labeling design software etc. Demonstrable applicable knowledge in FDA regulations and FDAICH guidelines are also required. Demonstrable acceptable skills in oral and written communications, independent judgment, problem solving and effective managing and adhering to timelines.

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

2019-06-20

SWA Job Order End Date

2019-07-25

Sunday Edition Newspaper

Y

First Newspaper Name

NY Daily News

First Advertisement Start Date

2019-06-30

Second Newspaper Ad Name

NY Daily News

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-07-07

Employer Website From Date

2020-01-01 07:36:16

Employer Website To Date

2020-01-01 07:36:16

Professional Organization Ad From Date

2020-01-01 07:36:16

Professional Organization Advertisement To Date

2020-01-01 07:36:16

Job Search Website From Date

2019-06-28

Job Search Website To Date

2019-07-27

Employee Referral Program From Date

2019-06-26

Employee Referral Program To Date

2019-07-18

Local Ethnic Paper From Date

2019-07-04

Local Ethnic Paper To Date

2019-07-04

Radio/TV Ad From Date

2020-01-01 07:36:16

Radio/TV Ad To Date

2020-01-01 07:36:16

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

PHARMACY ADMINISTRATION REGULATORY AFFAIRS AND QA

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

ST. JOHNS UNIVERSITY

Foreign Worker Education Institution Address 1

8000 UTOPIA PARKWAY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

JAMAICA

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11439

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

David H Nachman

Preparer Title

Managing Attorney

Preparer Email

david_nachman@visaserve.com

Employer Information Declaration Name

DeVaughn Stephens

Employer Information Declaration Title

Senior Manager, Human Resources