Fiscal Year

2021

Case Number

A-20281-08440

Case Status

Certified

Received Date

2020-10-07

Decision Date

2021-05-03

Refile

N

Original File Date

2021-01-01 09:19:13

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Cyclerion Therapeutics Inc

Employer Name Slug

cyclerion-therapeutics-inc

Employer Address 1

301 Binney 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

2142

Employer Phone

857-327-8778

Employer Number of Employees

86

Employer Year Commenced Business

2018

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Daryn Lewis

Employer Contact Address 1

301 Binney Street

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

857-338-3287

Employer Contact Email

dlewis@cyclerion.com

Agent Attorney Name

Laurie B Riccio

Agent Attorney Firm Name

Costa Riccio, LLP

Agent Attorney Phone

6177424444

Agent Attorney Address 1

18 Tremont Street, Suite 601

Agent Attorney Address 2

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2108

Agent Attorney Email

laurie@costariccio.com

PW Track Number

P10020041311136

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

84718.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-01

PW Expiration Date

2020-07-30

Wage Offer From

118000.22

Wage Offer To

0.00

Average Salary

118000.22

Wage Unit of Pay

Year

Worksite Address 1

301 Binney Street

Worksite Address 2

2nd Floor

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Manager, Global Regulatory Affairs

Job Title Slug

manager-global-regulatory-affairs

Minimum Education

Bachelor's

Major Field of Study

Life sciences, or (cont. in H-14)

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

A closely related health discipline to life sciences cont. in H14

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

3

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Work experience in the job offered cont. in H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

H4B cont. a closely related health discipline such as Regulatory Affairs or Pharmacy.br H7A cont. such as Regulatory Affairs or Pharmacy.br H10B or in the pharmaceutical or biotechnology industry, including three years of work experience in Regulatory Affairs; or in the alternative, a Masters degree or equivalent in the above fields and three years of work experience in the job offered or in the pharmaceutical or biotechnology industry, including two years of work experience in Regulatory Affairs.br br Special Skillsbr br If qualifying by Bachelors degree or equivalent, must have at least three years of experience working within US Food and Drug Administration FDA regulations and guidelines related to drug development, as well as leading the preparation and submission of regulatory documents to the FDA, including routine submissions of investigational new drug application IND investigator monthly regulatory packages, IND amendments, new IND submissions. Must have at least five years of experience working in a cross functional team environment, collaborating with onsite and remote team members. Must have at least two years of experience in rare or orphan disease drug development in Regulatory Affairs.br br If qualifying by Masters degree or equivalent, must have at least two years of experience working within US FDA regulations and guidelines related to drug development, as well as leading the preparation and submission of regulatory documents to the FDA, including routine submissions of IND investigator monthly regulatory packages, IND amendments, new IND submissions. Must have at least three years of experience working in a cross functional team environment, collaborating with onsite and remote team members. Must have at least one year of experience in rare or orphan disease drug development in Regulatory Affairs.

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

2020-07-22

SWA Job Order End Date

2020-08-24

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2020-08-09

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-08-16

Employer Website From Date

2020-07-22

Employer Website To Date

2020-08-25

Professional Organization Ad From Date

2021-01-01 09:19:13

Professional Organization Advertisement To Date

2021-01-01 09:19:13

Job Search Website From Date

2020-08-10

Job Search Website To Date

2020-08-25

Employee Referral Program From Date

2021-01-01 09:19:13

Employee Referral Program To Date

2021-01-01 09:19:13

Local Ethnic Paper From Date

2021-01-01 09:19:13

Local Ethnic Paper To Date

2021-01-01 09:19:13

Radio/TV Ad From Date

2021-01-01 09:19:13

Radio/TV Ad To Date

2021-01-01 09:19:13

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

2014

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

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

2155

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Laurie B Riccio

Preparer Title

Partner

Preparer Email

laurie@costariccio.com

Employer Information Declaration Name

Daryn Lewis

Employer Information Declaration Title

Vice President, People