Fiscal Year

2020

Case Number

A-19266-61350

Case Status

Certified-Expired

Received Date

2019-09-26

Decision Date

2019-11-27

Refile

N

Original File Date

2020-01-01 08:01:51

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Fresenius USA Marketing Inc

Employer Name Slug

fresenius-usa-marketing-inc

Employer Address 1

920 Winter St

Employer Address 2

Employer City

Waltham

Employer City Slug

waltham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2451

Employer Phone

781-6999459

Employer Number of Employees

62679

Employer Year Commenced Business

1999

NAICS Code

621399

FW Ownership Interest

N

Employer Contact Name

Jeannine Foley

Employer Contact Address 1

920 Winter St

Employer Contact Address 2

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2451

Employer Contact Phone

781-6999459

Employer Contact Email

jeannine.foley@fmc-na.com

Agent Attorney Name

Donald Parker

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

460 Totten Pond Road

Agent Attorney Address 2

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

dparker@parkergallini.com

PW Track Number

P10019023363350

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

72446.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-08

PW Expiration Date

2019-08-06

Wage Offer From

98984.70

Wage Offer To

0.00

Average Salary

98984.70

Wage Unit of Pay

Year

Worksite Address 1

920 Winter St.

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

Regulatory Affairs Associate, Pharmaceuticals

Job Title Slug

regulatory-affairs-associate-pharmaceuticals

Minimum Education

Master's

Major Field of Study

Regulatory Affairs or a 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

12

Accept Alternative Job Title

Regulatory Affairs Specialist

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Position requires a Masters degree in Regulatory Affairs or a closely related field and 1 year of experience as a Regulatory Affairs Specialist. This experience must include at least 6 months of experience which can be gained concurrently with the primary experience requirement above working with the following i preparing and reviewing post approval submissions for New Drug Applications NDA and Abbreviated New Drug Applications ANDA; ii authoring and reviewing Standard Operating procedures relating to quality testing and regulatory compliance processes; iii performing reviews and quality checks of regulatory submissions prior to submitting to the U.S. FDA to ensure compliance with US FDA format and content standards; iv providing FDA regulatory guidance and opinions to manufacturing and quality assurance teams; and v FDA Guidance documents, Title 21 Code of Federal Regulations, FDA regulations relating to new drug submissions and advertising and promotional issues and the International Council for Harmonization s ICH Guidelines.

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

2019-05-17

SWA Job Order End Date

2019-06-19

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2019-05-19

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-05-26

Employer Website From Date

2019-05-17

Employer Website To Date

2019-05-31

Professional Organization Ad From Date

2020-01-01 08:01:51

Professional Organization Advertisement To Date

2020-01-01 08:01:51

Job Search Website From Date

2019-05-21

Job Search Website To Date

2019-05-28

Employee Referral Program From Date

2020-01-01 08:01:51

Employee Referral Program To Date

2020-01-01 08:01:51

Local Ethnic Paper From Date

2019-05-24

Local Ethnic Paper To Date

2019-05-26

Radio/TV Ad From Date

2020-01-01 08:01:51

Radio/TV Ad To Date

2020-01-01 08:01:51

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

REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

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

Donald W Parker

Preparer Title

Attorney

Preparer Email

DParker@parkergallini.com

Employer Information Declaration Name

Jeannine Foley

Employer Information Declaration Title

Sr. Associate, Global Mobility Immigration Prog