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Case Number: A-21312-69522

Fiscal year: 2022

Fiscal Year

2022

Case Number

A-21312-69522

Case Status

Certified

Received Date

2021-12-13

Decision Date

2022-09-06

Refile

N

Original File Date

2022-01-01 06:35:42

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Otsuka Pharmaceutical Development Commericalizat

Employer Name Slug

otsuka-pharmaceutical-development-commericalizat

Employer Address 1

508 Carnegie Center Drive

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

609-524-6788

Employer Number of Employees

466

Employer Year Commenced Business

2007

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Regina A Wheeler

Employer Contact Address 1

508 Carnegie Center Drive

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

609-608-4558

Employer Contact Email

[email protected]

Agent Attorney Name

Sufen Zhang

Agent Attorney Firm Name

Miles Stockbridge

Agent Attorney Phone

410-385-3608

Agent Attorney Address 1

100 Light Street

Agent Attorney Address 2

Agent Attorney City

Baltimore

Agent Attorney State/Province

MARYLAND

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

21202

Agent Attorney Email

[email protected]

PW Track Number

P10021046077282

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level IV

PW Wage

96450.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-07-06

PW Expiration Date

2022-06-30

Wage Offer From

96450.00

Wage Offer To

112229.00

Average Salary

104339.50

Wage Unit of Pay

Year

Worksite Address 1

508 Carnegie Center Drive

Worksite Address 2

Worksite City

Princeton

Worksite City Slug

princeton

Worksite State

NEW JERSEY

Worksite Postal Code

8540

Job Title

Senior Regulatory Operations Associate

Job Title Slug

senior-regulatory-operations-associate

Minimum Education

Bachelor's

Major Field of Study

Pharmacy, Product Safety, Regulatory Affairs, or closely related field.

Required Training

N

Required Experience

N

Required Experience Months

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

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

48

Accept Alternative Job Title

Any position that provides the required experience.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors degree, or foreign equivalent, in Pharmacy, Product Safety, Regulatory Affairs, or another closely related field.br br Four 4 years of related work experience to include the followingbr Regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving eCTD sequences.br FDAEMAHCSwiss Medic regulations and guidance for electronic and paper submissions.br Managing and producing timesensitive eCTD ready submissions and other document publishing deliverables.br Document Management Systems Documentum and publishing tools, Lorenz DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox.br NDAs New Drug Application and MAAs Marketing Authorization Application.

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

2021-08-23

SWA Job Order End Date

2021-09-22

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2021-08-29

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-09-05

Employer Website From Date

2021-09-07

Employer Website To Date

2021-09-24

Professional Organization Ad From Date

2022-01-01 06:35:42

Professional Organization Advertisement To Date

2022-01-01 06:35:42

Job Search Website From Date

2021-08-30

Job Search Website To Date

2021-09-13

Employee Referral Program From Date

2022-01-01 06:35:42

Employee Referral Program To Date

2022-01-01 06:35:42

Local Ethnic Paper From Date

2021-09-03

Local Ethnic Paper To Date

2021-09-03

Radio/TV Ad From Date

2022-01-01 06:35:42

Radio/TV Ad To Date

2022-01-01 06:35:42

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

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Sufen Zhang

Preparer Title

Principal

Preparer Email

[email protected]

Employer Information Declaration Name

Regina A Wheeler

Employer Information Declaration Title

Manager, Mobility and Immigration Services