Fiscal Year

2022

Case Number

A-21245-39681

Case Status

Certified

Received Date

2021-11-03

Decision Date

2022-05-13

Refile

N

Original File Date

2022-01-01 11:27:16

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

WAVE Life Sciences USA, Inc.

Employer Name Slug

wave-life-sciences-usa-inc

Employer Address 1

733 Concord Avenue

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

2138

Employer Phone

617-949-2900

Employer Number of Employees

226

Employer Year Commenced Business

2009

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Michelene Flanigon

Employer Contact Address 1

733 Concord Avenue

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2138

Employer Contact Phone

617-949-2959

Employer Contact Email

mflanigon@wavelifesci.com

Agent Attorney Name

Bethany S Mandell

Agent Attorney Firm Name

Mandell Law Offices

Agent Attorney Phone

6179398110

Agent Attorney Address 1

Mandell Law Offices

Agent Attorney Address 2

Riverside Center, 275 Grove Street, Suite 2-400

Agent Attorney City

Newton

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2466

Agent Attorney Email

bmandell@mandellimmigration.com

PW Track Number

P10020233780418

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

106413.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-01-26

PW Expiration Date

2021-06-30

Wage Offer From

165000.00

Wage Offer To

0.00

Average Salary

165000.00

Wage Unit of Pay

Year

Worksite Address 1

115 Hartwell Avenue

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Associate Director, Regulatory Affairs

Job Title Slug

associate-director-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Regulatory Affairs or Related Degree

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

12

Accept Alternative Job Title

Experience in regulatory affairs development and administration in biotechnology environment

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Position requires a Masters degree, or foreign equivalent, in Regulatory Affairs or a related field plus a minimum of 1 year experience in regulatory affairs development and administration in biotechnology environment.br br Experience must include the following, which may be gained concurrentlybr br 1 year of experience in the application of USEU regulatory CMC requirements for early stage development as well as stage appropriate development consideration throughout product lifecycle e.g., development of Phase 1 appropriate manufacturing dossier;br br 1 year experience in regulatory strategy development to enable drug development and registration including experience in new INDEU CTA workplan and submission strategy, document development, breakthrough designation andor PRIME request package and associated meeting materials, global NDA submission plan and Module 3 development strategy;br br 1 year experience in project management of complex regulatory submissions e.g. new CTA including application of content knowledge under FDCA and European Directives;br br 1 year experience in drafting and preparation of regulatory submissions for therapeutics candidates in accordance with ICH, FDA and EMA guidelines;br br 1 year experience in applying eCTD structure to performing INDCTANDA lifecycle management including de novo applications, scaleupcomparability protocols and associated manufacturing process change amendments; andbr br Authorship of at least 25 technical CMC regulatory submissions for US IND and European CTA documents

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

2021-05-21

SWA Job Order End Date

2021-06-24

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Sunday Globe

First Advertisement Start Date

2021-06-13

Second Newspaper Ad Name

The Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-20

Employer Website From Date

2021-05-17

Employer Website To Date

2021-07-01

Professional Organization Ad From Date

2022-01-01 11:27:16

Professional Organization Advertisement To Date

2022-01-01 11:27:16

Job Search Website From Date

2021-06-07

Job Search Website To Date

2021-06-21

Employee Referral Program From Date

2022-01-01 11:27:16

Employee Referral Program To Date

2022-01-01 11:27:16

Local Ethnic Paper From Date

2021-06-09

Local Ethnic Paper To Date

2021-06-09

Radio/TV Ad From Date

2022-01-01 11:27:16

Radio/TV Ad To Date

2022-01-01 11:27:16

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

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

BOSTON CAMPUS

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

Bethany S Mandell

Preparer Title

Attorney

Preparer Email

bmandell@mandellimmigration.com

Employer Information Declaration Name

Michelene Flanigon

Employer Information Declaration Title

Senior Director, Human Resources