TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Global Regulatory Labeling Strategy Manager

A-22251-18233 H-1B 2023 Certified

Salary

$111,904

Visa Type

H-1B

Job Title

Global Regulatory Labeling Strategy Manager

Employee's Citizenship

TUNISIA

Graduate School

UNIVERSITY OF MONASTIR

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22251-18233

Case Status Certified

Received Date 2022-09-22

Decision Date 2023-08-14

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Employer Address_Line 1 95 HAYDEN AVE

Employer Address_Line 2 -

Employer City LEXINGTON

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 2421

Employer Phone No. 224-544-1749

Employer Phone Extent No. -

Total Number of Employees 18000

Employer Year of Commenced 2003

NAICS Code 325411

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Ken Brown

Employer Contact Address Line1 95 Hayden Ave

Employer Contact Address Line2 -

Employer Contact City Lexington

Employer Contact State/ Provice MASSACHUSETTS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 2421

Employer Contact Phone 617-794-2549

Employer Contact Email ken.brown@takeda.com

Attorney

11 fields

Agent/ Attorney Name Susie Shin

Agent/ Attorney Firm Name Zulkie Partners LLC

Agent/ Attorney Phone (312) 831-2127

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 135 South La Salle Street

Agent/ Attorney Address Line 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 sshin@zulkiepartners.com

Position Info

89 fields

Prevailing Wage Track Number P10021195460975

Prevailing Wage SOC Code 11-9199

Prevailing Wage SOC Title Managers, All Others

Prevailing Wage Skill Level Level II

Prevailing Wage 111904

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-03-07

Prevailing Wage Expiration Date 2022-06-30

Wage Offer From 124600

Wage Offer To 240300

Wage Offer Unit of Pay Year

Workstie Address Line 1 650 E. Kendall Street

Worksite Address Line 2 -

Worksite City Cambridge

Worksite State MASSACHUSETTS

Worksite Postal Code 2140

Job Title Global Regulatory Labeling Strategy Manager

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Chemistry, Pharmacy or closely related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study N

Accept Alternate Major -

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 36

Accept Alternate Job Title GLOBAL REGULATORY LABELING STRATEGY MANAGER OR RELATED

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills Prior experience must include provide labeling strategy by assessing globallocal labeling regulations, competitor labeling, labeling trends, collating historical Health Authority feedback, and company internal data to optimize the product labeling for the benefit of the patient while ensuring regulatory compliance; collaborate with the crossfunctional teams to authorreviewupdate company core data sheet CCDS, regionallocal labeling USPI and EU SmPC and supporting documentation for regulatory submissions; prepare response documents and backup strategies for label negotiations with Health Authorities to address the labelingrelated queries by interpreting clinical and scientific data from Clinical study reports, Safety summaries, toxicology reports, chemistrymanufacturing reports and other sources; evaluate risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead. Up to 5 travel required.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-04-06

Job Oder End Date 2022-05-09

Sunday Edition Newspaper Y

First Newspaper Name Boston Sunday Globe

First Advertisement Start Date 2022-04-10

Second Newspaper Name Boston Sunday Globe

Second Advertisement Type Newspaper

Second Ad Start Date 2022-04-17

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-04-06

Employer Website to Date 2022-06-17

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-06-01

Job Search Website to Date 2022-06-17

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-04-14

Local Ethnic Newspaper to Date 2022-04-14

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship TUNISIA

Foreign Worker Birth Country TUNISIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Bachelor's

Foreign Worker Education Other -

Foreign Worker Major PHARMACY

Year of Compelted Education 2016

Foreign Worker Istitution of Eduation UNIVERSITY OF MONASTIR

Foreign Worker Education Instution Address Line 1 RUE IBN SINA

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City MONASTIR

Foreign Worker Educatution Institution State -

Foreign Worker Education Institution Country TUNISIA

Foreign Worker Education Training Post Code 5000

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Susie Shin

Preparer Title Principal

Preparer Email sshin@zulkiepartners.com

Employer Information Declaration Name Ken Brown

Employer Declaration Title Global Mobility Strategy Lead