Fiscal Year

2024

Case Number

A-23019-89370

Case Status

Certified

Received Date

2023-01-25

Decision Date

2024-03-01

Refile

N

Original File Date

2024-01-01 00:50:29

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SHIRE HUMAN GENETIC THERAPIES SHGT INC

Employer Name Slug

shire-human-genetic-therapies-shgt-inc

Employer Address 1

300 SHIRE WAY

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

781-482-0599

Employer Number of Employees

19608

Employer Year Commenced Business

1994

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ken Brown

Employer Contact Address 1

300 Shire Way

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

6177942549

Employer Contact Email

ken.brown@takeda.com

Agent Attorney Name

Nana A OtutuaAmoah

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2131

Agent Attorney Address 1

135 S. LaSalle Street

Agent Attorney Address 2

Ste. 3425

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

namoah@zulkiepartners.com

PW Track Number

P10022062949758

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

2022-09-06

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

300 Shire Way

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Team Lead, Global Reg Affairs Device, PDT

Job Title Slug

team-lead-global-reg-affairs-device-pdt

Minimum Education

Master's

Major Field of Study

Regulatory Affairs or related field or foreign academic equivalent

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

60

Accept Alternative Job Title

Senior Manager, Scientist II, Principal Specialist or related position.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Lead a team of engineers and specialists through device combination product projects creating compliant design history files towards regulator dossiers for agency submission 5 yrs; coordinate and guide a team of regulatory labelling specialists to produce instruction for use documents for the safe use of drug delivery devices 3 yrs; negotiate with global regulatory agencies and persuade the agencies to accept data packages towards drug device approval 5 yrs; monitor and assess regulatory guidelines and standards for the successful and compliant development of device drug combination product modalities 3 yrs. 15 travel required.

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

2022-09-16

SWA Job Order End Date

2022-10-18

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Sunday Globe

First Advertisement Start Date

2022-09-18

Second Newspaper Ad Name

Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-09-25

Employer Website From Date

2022-09-16

Employer Website To Date

2022-11-30

Professional Organization Ad From Date

2024-01-01 00:50:29

Professional Organization Advertisement To Date

2024-01-01 00:50:29

Job Search Website From Date

2022-09-19

Job Search Website To Date

2022-10-19

Employee Referral Program From Date

2024-01-01 00:50:29

Employee Referral Program To Date

2024-01-01 00:50:29

Local Ethnic Paper From Date

2022-09-22

Local Ethnic Paper To Date

2022-09-22

Radio/TV Ad From Date

2024-01-01 00:50:29

Radio/TV Ad To Date

2024-01-01 00:50:29

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CANADA

Foreign Worker Birth Country

CANADA

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

UNIVERSITY OF WALES

Foreign Worker Education Institution Address 1

KING EDWARD VII AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CARDIFF

Foreign Worker Education Institution State/Province

WALES

Foreign Worker Education Institution Country

UNITED KINGDOM

Foreign Worker Education Institution Postal Code

CF10 3NS

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Nana A OtutuaAmoah

Preparer Title

Associate

Preparer Email

namoah@zulkiepartners.com

Employer Information Declaration Name

Ken Brown

Employer Information Declaration Title

Global Mobility Strategy Lead