Fiscal Year

2024

Case Number

A-23082-17418

Case Status

Certified

Received Date

2023-03-23

Decision Date

2024-04-11

Refile

N

Original File Date

2024-01-01 01:03:03

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Employer Name Slug

takeda-development-center-americas-inc

Employer Address 1

95 HAYDEN AVE

Employer Address 2

Employer City

LEXINGTON

Employer City Slug

lexington

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2421

Employer Phone

224-544-1749

Employer Number of Employees

19608

Employer Year Commenced Business

2003

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ken Brown

Employer Contact Address 1

95 Hayden Ave

Employer Contact Address 2

Employer Contact City

Lexington

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2421

Employer Contact Phone

617-794-2549

Employer Contact Email

ken.brown@takeda.com

Agent Attorney Name

Susan M MacLean

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2129

Agent Attorney Address 1

135 S. La Salle Street

Agent Attorney Address 2

Suite 3425

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603-4177

Agent Attorney Email

smaclean@zulkiepartners.com

PW Track Number

P10022131159373

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

180294.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-11-30

PW Expiration Date

2023-06-30

Wage Offer From

181000.00

Wage Offer To

287000.00

Average Salary

234000.00

Wage Unit of Pay

Year

Worksite Address 1

500 Kendall Street

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Associate Director, Global Regulatory Affairs Marketed Products

Job Title Slug

associate-director-global-regulatory-affairs-marketed-products

Minimum Education

Bachelor's

Major Field of Study

Scientific Discipline

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

96

Accept Alternative Job Title

Regulatory Affairs Manager or related occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Prior experience must include at least 6 years of experience with each of the following Apply FDA, EMA and Health Canada regulations to design and execute regulatory strategies to maintain registration and ensure global regulatory compliance; plan and manage regulatory submissions for global submissions considering company goals, procedural timelines and regulations for life cycle management; lead regulatory strategies, chair meetings and negotiate favorable outcomes with FDA. Travel required up to 30 of time. May work from home 2075; must live within commuting distance of office.

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

2023-01-16

SWA Job Order End Date

2023-02-16

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2023-01-15

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-01-22

Employer Website From Date

2023-01-13

Employer Website To Date

2023-02-16

Professional Organization Ad From Date

2024-01-01 01:03:03

Professional Organization Advertisement To Date

2024-01-01 01:03:03

Job Search Website From Date

2023-01-16

Job Search Website To Date

2023-02-13

Employee Referral Program From Date

2024-01-01 01:03:03

Employee Referral Program To Date

2024-01-01 01:03:03

Local Ethnic Paper From Date

2023-01-26

Local Ethnic Paper To Date

2023-01-26

Radio/TV Ad From Date

2024-01-01 01:03:03

Radio/TV Ad To Date

2024-01-01 01:03:03

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 MEDICAL DEVICES

Foreign Worker Years of Education Completed

2011

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

Susan M MacLean

Preparer Title

Principal

Preparer Email

smaclean@zulkiepartners.com

Employer Information Declaration Name

Ken Brown

Employer Information Declaration Title

Global Mobility Strategy Lead