Fiscal Year

2022

Case Number

A-21351-88174

Case Status

Certified

Received Date

2021-12-21

Decision Date

2022-08-05

Refile

N

Original File Date

2022-01-01 11:49:36

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SANOFI PASTEUR, INC

Employer Name Slug

sanofi-pasteur-inc

Employer Address 1

1 DISCOVERY DRIVE

Employer Address 2

Employer City

SWIFTWATER

Employer City Slug

swiftwater

Employer State

PENNSYLVANIA

Employer State Slug

pennsylvania

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

18370

Employer Phone

570-839-7187

Employer Number of Employees

3106

Employer Year Commenced Business

1978

NAICS Code

325414

FW Ownership Interest

N

Employer Contact Name

Janet L DErrico

Employer Contact Address 1

225 Second Avenue

Employer Contact Address 2

#2SS37

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2451

Employer Contact Phone

781-663-9057

Employer Contact Email

janet.derrico@sanofi.com

Agent Attorney Name

Ian P Band

Agent Attorney Firm Name

Hunton Andrews Kurth, LLP

Agent Attorney Phone

(202) 955-1913

Agent Attorney Address 1

2200 Pennsylvania Avenue NW

Agent Attorney Address 2

Agent Attorney City

Washington

Agent Attorney State/Province

DISTRICT OF COLUMBIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

20037

Agent Attorney Email

iband@huntonak.com

PW Track Number

P10021077156751

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

94952.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-08-18

PW Expiration Date

2022-06-30

Wage Offer From

95000.00

Wage Offer To

165000.00

Average Salary

130000.00

Wage Unit of Pay

Year

Worksite Address 1

1 Discovery Drive

Worksite Address 2

Worksite City

Swiftwater

Worksite City Slug

swiftwater

Worksite State

PENNSYLVANIA

Worksite Postal Code

18370

Job Title

Regulatory CMC Vaccines Manager

Job Title Slug

regulatory-cmc-vaccines-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

Y

Required Experience Months

12

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biological sciences or a related field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

2

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

12

Accept Alternative Job Title

Related position

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Experience must include 1 year in regulatory affairs authoring modules 2 and 3 of the Common Technical Document CTD; Chemistry Manufacturing and Controls CMC; North American, European, and international regulations and guidelines related to biological products; serving as a regulatory representative on crossfunctional project teams working on a developmental biological product intended for international license; and microbiology, immunology, virology, or bacteriology.br br Will also accept a Bachelors degree in biological sciences or a related field and 2 years of regulatory affairs experience, including 1 year in regulatory affairs authoring modules 2 and 3 of the Common Technical Document CTD; Chemistry Manufacturing and Controls CMC; North American, European, and international regulations and guidelines related to biological products; serving as a regulatory representative on crossfunctional project teams working on a developmental biological product intended for international license; and microbiology, immunology, virology, or bacteriology in lieu of a masters degree and 1 year of experience.br br Will accept an suitable combination of education and experience, but no less than a bachelors degree and 2 years of experience.

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

2021-10-12

SWA Job Order End Date

2021-11-11

Sunday Edition Newspaper

Y

First Newspaper Name

Pocono Record

First Advertisement Start Date

2021-10-17

Second Newspaper Ad Name

Pocono Record

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-10-24

Employer Website From Date

2022-01-01 11:49:36

Employer Website To Date

2022-01-01 11:49:36

Professional Organization Ad From Date

2021-10-12

Professional Organization Advertisement To Date

2021-10-26

Job Search Website From Date

2021-10-11

Job Search Website To Date

2021-10-25

Employee Referral Program From Date

2022-01-01 11:49:36

Employee Referral Program To Date

2022-01-01 11:49:36

Local Ethnic Paper From Date

2022-01-01 11:49:36

Local Ethnic Paper To Date

2022-01-01 11:49:36

Radio/TV Ad From Date

2021-10-26

Radio/TV Ad To Date

2021-10-26

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

DRUG REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY DRIVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Ian P Band

Preparer Title

Attorney

Preparer Email

iband@huntonak.com

Employer Information Declaration Name

Janet L DErrico

Employer Information Declaration Title

US Immigration Manager