Fiscal Year

2020

Case Number

A-19304-77748

Case Status

Certified

Received Date

2019-11-19

Decision Date

2020-04-10

Refile

N

Original File Date

2020-01-01 08:13:51

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDENBRIDGE PHARMACEUTICALS, LLC

Employer Name Slug

edenbridge-pharmaceuticals-llc

Employer Address 1

169 LACKAWANNA AVENUE

Employer Address 2

SUITE 110

Employer City

PARSIPPANY

Employer City Slug

parsippany

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7054

Employer Phone

201-292-1292

Employer Number of Employees

31

Employer Year Commenced Business

2008

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Daniel G Worley

Employer Contact Address 1

169 Lackawanna Avenue

Employer Contact Address 2

Suite 110

Employer Contact City

Parsippany

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7054

Employer Contact Phone

201-479-1336

Employer Contact Email

dworley@edenbridgepharma.com

Agent Attorney Name

Michelle A White

Agent Attorney Firm Name

Littler Mendelson P.C.

Agent Attorney Phone

3054007549

Agent Attorney Address 1

Wells Fargo Center, 333 SE 2nd Avenue

Agent Attorney Address 2

Suite 2700

Agent Attorney City

Miami

Agent Attorney State/Province

FLORIDA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

33131

Agent Attorney Email

MAWhite@littler.com

PW Track Number

P10019032141977

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

168272.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-17

PW Expiration Date

2019-08-15

Wage Offer From

168272.00

Wage Offer To

0.00

Average Salary

168272.00

Wage Unit of Pay

Year

Worksite Address 1

169 Lackawanna Avenue

Worksite Address 2

Suite 110

Worksite City

Parsippany

Worksite City Slug

parsippany

Worksite State

NEW JERSEY

Worksite Postal Code

7054

Job Title

Associate Director, Regulatory Affairs

Job Title Slug

associate-director-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Chemistry Pharmaceutical Sciences

Required Training

N

Required Experience

Y

Required Experience Months

84

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

REGULATORY AFFAIRS OR RELATED

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

84

Accept Alternative Job Title

Reg. Affairs Sr. Associate, Reg. Affairs Manager, Reg. Affairs Associate

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

MIN. REQUIREMENTS MASTERS DEGREE OR FOREIGN EQUIVALENT IN SCIENCE, CHEMISTRY PHARMACEUTICAL SCIENCES, REGULATORY AFFAIRS OR RELATED; AND 7br YEARS WORK EXPERIENCE IN US FDA REGULATED PHARMACEUTICAL DEVELOPMENT AND MANUFACTURING.br SPECIFIC SKILLS OR OTHER REQUIREMENTSbr 7 YEARS OF EXPERIENCE WITH US FDA ANDA SUBMISSIONS IN ECTD FORMAT REQUIRED.br 7 YEARS OF EXPERIENCE INDEPENDENTLY DRAFTING ANDA AND OTHER FDA SUBMISSIONS AND RESPONDING DIRECTLY TO THE FDA.br 7 YEARS OF EXPERIENCE AND PROFICIENCY IN ECTD SOFTWARE FOR COMPILATION AND SUBMISSION OF REGULATORY FILINGS.br 7 YEARS OF REGULATORY EXPERIENCE IN MULTIPLE DOSAGE FORMS INCLUDING ORAL SOLID, INJECTABLE, OPHTHALMIC AND TRANSDERMAL PRODUCTS.br EXPERIENCE WITH REGULATORY AFFAIRS DUE DILIGENCE FOR MA TRANSACTIONS.br DIRECT LABORATORY EXPERIENCE IN EITHER FORMULATION RD OR ANALYTICAL CHEMISTRY.

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

2019-07-15

SWA Job Order End Date

2019-08-19

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2019-07-21

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-07-28

Employer Website From Date

2019-09-12

Employer Website To Date

2019-09-25

Professional Organization Ad From Date

2020-01-01 08:13:51

Professional Organization Advertisement To Date

2020-01-01 08:13:51

Job Search Website From Date

2019-07-21

Job Search Website To Date

2019-08-19

Employee Referral Program From Date

2020-01-01 08:13:51

Employee Referral Program To Date

2020-01-01 08:13:51

Local Ethnic Paper From Date

2019-07-17

Local Ethnic Paper To Date

2019-07-17

Radio/TV Ad From Date

2020-01-01 08:13:51

Radio/TV Ad To Date

2020-01-01 08:13:51

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

PHARMACEUTICAL CHEMISTRY

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

FAIRLEIGH DICKINSON UNIVERSITY

Foreign Worker Education Institution Address 1

285 MADISON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MADISON

Foreign Worker Education Institution State/Province

NJ

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

7940

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Michelle A White

Preparer Title

Attorney at Law

Preparer Email

MAWhite@littler.com

Employer Information Declaration Name

Patrick Chu

Employer Information Declaration Title

President