Fiscal Year

2021

Case Number

A-20183-71786

Case Status

Certified-Expired

Received Date

2020-07-02

Decision Date

2021-02-03

Refile

N

Original File Date

2021-01-01 08:59:59

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

DR. REDDYS LABORATORIES

Employer Name Slug

dr-reddys-laboratories

Employer Address 1

107 COLLEGE ROAD EAST

Employer Address 2

Employer City

PRINCETON

Employer City Slug

princeton

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8540

Employer Phone

609-375-9871

Employer Number of Employees

615

Employer Year Commenced Business

1992

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Claudia Zapata

Employer Contact Address 1

107 College Road East

Employer Contact Address 2

Employer Contact City

Princeton

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

8540

Employer Contact Phone

609-375-9676

Employer Contact Email

czapata@drreddys.com

Agent Attorney Name

David H Nachman

Agent Attorney Firm Name

NPZ Law Group, P.C.

Agent Attorney Phone

2016700006

Agent Attorney Address 1

487 Goffle Road

Agent Attorney Address 2

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

P10019200024638

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Manager

PW Skill Level

Level II

PW Wage

117666.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-11-12

PW Expiration Date

2020-06-30

Wage Offer From

117666.00

Wage Offer To

0.00

Average Salary

117666.00

Wage Unit of Pay

Year

Worksite Address 1

107 College Road East

Worksite Address 2

Worksite City

Princeton

Worksite City Slug

princeton

Worksite State

NEW JERSEY

Worksite Postal Code

8540

Job Title

Manager, Regulatory Affairs

Job Title Slug

manager-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Drug Reg Affairs; Biotech; Molec Bio

Required Training

N

Required Experience

Y

Required Experience Months

12

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 Drug Regulatory Affairs, Biotechnology or Molecular Biology. The applicant must have 1 year of experience in Regulatory Affairs within a generic pharmaceutical environment. Must also have prior experience in the following Preparing, reviewing, electronic publishing and filing various types of regulatory submissions DMF ANDA NDA 505 b2 PIND IND Bio IND including amendments, annual reports, postapproval; and supplements, and presubmission documentation with USFDA and Health Canada. Must have demonstrable knowledge of state licensure and controlled substance registration and reporting requirements; reviewing labeling artworks, change controls, promotional materials etc for the RX and OTC products. Must have prior handson experience with the following Electronic publishing, structured product labeling, establishment registrations, selfidentifications, drug establishment licenses in Canada and familiarity with other GDUFA and PDUFA related compliance activities. Prior experience with complex drug products containing peptides, liposomes, and familiarity with advanced characterization techniques is needed. Demonstrable understanding of pharmaceutical development, manufacturing processes, analytical, clinical, nonclinical, microbiologysterility and c GMP requirements, relevant regulations and guidance issued by FDA, HC, and ICH. The Applicant must also have the ability to navigate the required information from the FDA and state pharmacy board websites.

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

2020-01-29

SWA Job Order End Date

2020-03-04

Sunday Edition Newspaper

Y

First Newspaper Name

The Times of Trenton

First Advertisement Start Date

2020-01-19

Second Newspaper Ad Name

The Times of Trenton

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-01-26

Employer Website From Date

2020-01-06

Employer Website To Date

2020-04-05

Professional Organization Ad From Date

2021-01-01 08:59:59

Professional Organization Advertisement To Date

2021-01-01 08:59:59

Job Search Website From Date

2020-01-19

Job Search Website To Date

2020-02-01

Employee Referral Program From Date

2020-01-29

Employee Referral Program To Date

2020-03-05

Local Ethnic Paper From Date

2021-01-01 08:59:59

Local Ethnic Paper To Date

2021-01-01 08:59:59

Radio/TV Ad From Date

2021-01-01 08:59:59

Radio/TV Ad To Date

2021-01-01 08:59:59

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

BIOTECHNOLOGY, SPECIALIZED IN MOLECULAR BIOTECHNOLOGY

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

UNIVERSITY OF HOUSTON CLEAR LAKE

Foreign Worker Education Institution Address 1

2700 BAY AREA BLVD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

HOUSTON

Foreign Worker Education Institution State/Province

TX

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

77058

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

Claudia Zapata

Employer Information Declaration Title

Recruitment Partner