TAKEDA VACCINES, INC.

Manager - Regulatory Operations, Labeling, & Compliance

A-22238-12489 H-1B 2023 Certified

Salary

$58,219

Visa Type

H-1B

Job Title

Manager - Regulatory Operations, Labeling, & Compliance

Employee's Citizenship

INDIA

Graduate School

KAKATIYA UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22238-12489

Case Status Certified

Received Date 2022-08-26

Decision Date 2023-06-08

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 VACCINES, INC.

Employer Address_Line 1 75 SIDNEY STREET

Employer Address_Line 2 -

Employer City CAMBRIDGE

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 2139

Employer Phone No. 224.940.3404

Employer Phone Extent No. -

Total Number of Employees 19608

Employer Year of Commenced 2012

NAICS Code 541720

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Ken Brown

Employer Contact Address Line1 45 Hayden Avenue

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 P10021334731978

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Compliance Officers

Prevailing Wage Skill Level Level I

Prevailing Wage 58219

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-06-06

Prevailing Wage Expiration Date 2022-09-04

Wage Offer From 101500

Wage Offer To 195800

Wage Offer Unit of Pay Year

Workstie Address Line 1 75 Sidney Street

Worksite Address Line 2 -

Worksite City Cambridge

Worksite State MASSACHUSETTS

Worksite Postal Code 2139

Job Title Manager - Regulatory Operations, Labeling, & Compliance

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Pharmacy or 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 24

Accept Alternate Job Title Regulatory Affairs Associate or related position

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Will accept any level of experience in the following skills Veeva System for Global Regulatory Information Management RIM, Document Management and Registrations, Clinical Study Reports; Execute UAT User Acceptance testing HP ALM for Veeva updates; ISI Toolbox for Regulatory Submission preparation, Webreview for submission documents review; TransPerfect for translation of documents to country specific languages; WebTCards for Tracking of Global Country Submissions; Global Submit Validate, EURS Validator and S3 browser for published output validation. This is a 100 telecommuting position.

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 2022-06-17

Job Oder End Date 2022-07-20

Sunday Edition Newspaper Y

First Newspaper Name The Boston Globe

First Advertisement Start Date 2022-06-19

Second Newspaper Name The Boston Globe

Second Advertisement Type Newspaper

Second Ad Start Date 2022-06-26

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-06-17

Employer Website to Date 2022-07-26

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-06-21

Job Search Website to Date 2022-07-18

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 2022-06-23

Local Ethnic Newspaper to Date 2022-06-23

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 INDIA

Foreign Worker Birth Country INDIA

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 2012

Foreign Worker Istitution of Eduation KAKATIYA UNIVERSITY

Foreign Worker Education Instution Address Line 1 NEAR AYYAPPA SWAMY TEMPLE, AREPALLY, MULUGU RD

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City WARANGAL

Foreign Worker Educatution Institution State TELANGANA

Foreign Worker Education Institution Country INDIA

Foreign Worker Education Training Post Code 506007

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