Fiscal Year

2020

Case Number

A-20091-37219

Case Status

Withdrawn

Received Date

2020-06-03

Decision Date

2020-08-17

Refile

N

Original File Date

2020-01-01 19:57:35

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

KASHIV BIOSCIENCES LLC.

Employer Name Slug

kashiv-biosciences-llc

Employer Address 1

995 US HWY 202206

Employer Address 2

Employer City

BRIDGEWATER

Employer City Slug

bridgewater

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8807

Employer Phone

9088951568

Employer Number of Employees

180

Employer Year Commenced Business

2010

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Charmaine Maskarenas

Employer Contact Address 1

995 US Hwy 202206

Employer Contact Address 2

Employer Contact City

Bridgewater

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

8807

Employer Contact Phone

9088951568

Employer Contact Email

charmaine@kashivbio.com

Agent Attorney Name

Anthony F Siliato

Agent Attorney Firm Name

Meyner and Landis LLP

Agent Attorney Phone

(973) 602-3440

Agent Attorney Address 1

One Gateway Center

Agent Attorney Address 2

2500

Agent Attorney City

Newark

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7102

Agent Attorney Email

asiliato@meyner.com

PW Track Number

P10019177010496

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialist

PW Skill Level

Level IV

PW Wage

98322.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-10-08

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

995 US HIGHWAY 202206

Worksite Address 2

Worksite City

BRIDGEWATER

Worksite City Slug

bridgewater

Worksite State

NEW JERSEY

Worksite Postal Code

8807

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

Regulatory Science

Required Training

N

Required Experience

Y

Required Experience Months

96

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Quality Assurance, Regulatory Affairs or rel. field.

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

96

Accept Alternative Job Title

Any occupation which includes the required exp.skills.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

eight 8 years of pharmaceutical industry and regulatory experience; six 6 years of demonstrated experience with health authority submissions; i.e, authored, reviewed and managed an originalsupplemental application IND, ANDA; six 6 years of eCTD publishing experience using MedXview and Educe Software; five 5 years of Regulatory Life Cycle management of ANDAs including Development, Promotion and Advertising, Labeling, CMC and Commercialization; advanced knowledge of domestic laws, regulations, and guidance that affect drug products; successful management of development milestones, and marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses; must have demonstrated an ability to influence and partner with crossfunctional teams in a pharmaceutical organization; must have demonstrated an ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval; must have demonstrated an ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data; and must have demonstrated an ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.

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

2020-01-23

SWA Job Order End Date

2020-02-25

Sunday Edition Newspaper

Y

First Newspaper Name

The Star Ledger

First Advertisement Start Date

2020-02-09

Second Newspaper Ad Name

The Star Ledger

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-02-16

Employer Website From Date

2020-01-24

Employer Website To Date

2020-02-11

Professional Organization Ad From Date

2020-01-01 19:57:35

Professional Organization Advertisement To Date

2020-01-01 19:57:35

Job Search Website From Date

2020-02-10

Job Search Website To Date

2020-03-09

Employee Referral Program From Date

2020-01-01 19:57:35

Employee Referral Program To Date

2020-01-01 19:57:35

Local Ethnic Paper From Date

2020-02-12

Local Ethnic Paper To Date

2020-02-12

Radio/TV Ad From Date

2020-01-01 19:57:35

Radio/TV Ad To Date

2020-01-01 19:57:35

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

QUALITY ASSURANCEREGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

TEMPLE UNIVERSITY

Foreign Worker Education Institution Address 1

1801 NORTH BROAD STREET

Foreign Worker Education Institution Address 2

CONWELL HALL

Foreign Worker Education Institution City

PHILADELPHIA

Foreign Worker Education Institution State/Province

PA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

19122

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Anthony F Siliato

Preparer Title

Partner

Preparer Email

asiliato@meyner.com

Employer Information Declaration Name

Charmaine Maskarenas

Employer Information Declaration Title

Senior Director, HR Services