Fiscal Year

2020

Case Number

A-19309-79469

Case Status

Certified

Received Date

2019-11-11

Decision Date

2020-04-07

Refile

N

Original File Date

2020-01-01 08:15:07

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MILLENNIUM PHARMACEUTICALS, INC.

Employer Name Slug

millennium-pharmaceuticals-inc

Employer Address 1

40 LANDSDOWNE STREET

Employer Address 2

Employer City

CAMBRIDGE

Employer City Slug

cambridge

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2139

Employer Phone

(617) 679-7000

Employer Number of Employees

8600

Employer Year Commenced Business

1993

NAICS Code

325411

FW Ownership Interest

N

Employer Contact Name

HLADNIK Denise

Employer Contact Address 1

One Takeda Parkway

Employer Contact Address 2

Employer Contact City

Deerfield

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60015

Employer Contact Phone

(224)-554-6500

Employer Contact Email

denise.hladnik@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

P10019108348861

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

159744.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-08-01

PW Expiration Date

2020-06-30

Wage Offer From

159800.00

Wage Offer To

222800.00

Average Salary

191300.00

Wage Unit of Pay

Year

Worksite Address 1

350 Massachusetts Avenue

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2139

Job Title

Senior Manager, Global Regulatory Affairs, CMC

Job Title Slug

senior-manager-global-regulatory-affairs-cmc

Minimum Education

Bachelor's

Major Field of Study

Pharmaceutical Sciences or a 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

72

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 5.5 years with each of the following develop and drive the execution of regulatory CMC development and registration strategies including interpretation and application of regulatory requirements as the regulatory CMC lead on crossfunctional project teams for global products throughout clinical development and commercial lifecycle; lead and implement regulatory CMC submission activities for global products including planning, authoring, reviewing, coordination, submission that includes ensuring compliance with major markets e.g. US, EU, Canada and emerging markets e.g. Asia, LATAM, Africa regulatory guidelines; plan, execute and manage regulatory submissions for compounds in various phases of clinical development including INDIMPDCTA, Briefing Book, marketing applications NDAMAA, and postapproval life cycle activities variationsupplements for both major markets e.g. US, EU, Canada emerging markets e.g. Asia, LATAM, Africa; define CMC data and documentation content data and documentation requirements for regulatory submissions, lead and drive crossfunctional CMC Health Authority Response Teams and review content for conformance with established requirements.

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

2019-09-10

SWA Job Order End Date

2019-10-10

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2019-09-08

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-09-15

Employer Website From Date

2019-08-29

Employer Website To Date

2019-10-10

Professional Organization Ad From Date

2020-01-01 08:15:07

Professional Organization Advertisement To Date

2020-01-01 08:15:07

Job Search Website From Date

2019-09-10

Job Search Website To Date

2019-09-20

Employee Referral Program From Date

2020-01-01 08:15:07

Employee Referral Program To Date

2020-01-01 08:15:07

Local Ethnic Paper From Date

2019-09-12

Local Ethnic Paper To Date

2019-09-12

Radio/TV Ad From Date

2020-01-01 08:15:07

Radio/TV Ad To Date

2020-01-01 08:15:07

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

O-1

Foreign Worker Education

Doctorate

Foreign Worker Information: Major

PHARMACEUTICAL SCIENCES

Foreign Worker Years of Education Completed

2005

Foreign Worker Institution of Education

BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCE, PILANI

Foreign Worker Education Institution Address 1

VIDYAVIHAR CAMPUS, PILANI, RAJASTHAN 333031

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

PILANI

Foreign Worker Education Institution State/Province

RAJASTHAN

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

333031

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

Denise F Hladnik

Employer Information Declaration Title

Immigration Manager