Fiscal Year

2022

Case Number

A-21179-08912

Case Status

Certified-Expired

Received Date

2021-08-30

Decision Date

2022-02-10

Refile

N

Original File Date

2022-01-01 10:54:56

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BIOGEN, INC.

Employer Name Slug

biogen-inc

Employer Address 1

225 BINNEY STREET

Employer Address 2

BUILDING 1

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

617-679-6299

Employer Number of Employees

5675

Employer Year Commenced Business

2003

NAICS Code

325411

FW Ownership Interest

N

Employer Contact Name

Cassie Ramos

Employer Contact Address 1

225 Binney Street

Employer Contact Address 2

Building 1

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

617-914-6925

Employer Contact Email

cassie.ramos@biogen.com

Agent Attorney Name

Sophia Rossi

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

(469) 290-9910

Agent Attorney Address 1

265 Franklin Street

Agent Attorney Address 2

Suite 502

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2110

Agent Attorney Email

srteam@bal.com

PW Track Number

P10020330928017

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level III

PW Wage

135554.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-04-08

PW Expiration Date

2021-07-07

Wage Offer From

135554.00

Wage Offer To

156000.00

Average Salary

145777.00

Wage Unit of Pay

Year

Worksite Address 1

225 BINNEY STREET

Worksite Address 2

Worksite City

CAMBRIDGE

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Manager, Regulatory Affairs

Job Title Slug

manager-regulatory-affairs

Minimum Education

Bachelor's

Major Field of Study

See H.14

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.14

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

36

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Bachelors degree in Life Sciences, Engineering, Biotechnology, Pharmaceutical Science, Regulatory Affairs, or a directly related field plus three 3 years of experience in the pharmaceutical industry or a regulatory authority CMC review capacity.br br Must have 3 years of experience in each of the following experience may be gained concurrentlybr Experience in Regulatory CMCbr Registration experience working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and postapproval productsbr Knowledge of GMP requirements and standard systemsbr Knowledge of regulatory authoring systemsbr Leading crossfunctional teamsbr Experience managing projects across global locationstime zones.br Experience in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical pathsbr Must have 2 years of experience in each of the following experience may be gained concurrentlybr Direct communication and negotiation with regulatory agencies on CMC mattersbr Experience in pharmaceutical manufacturing, analytical development, and quality assurancecontrol or related technical field life sciences, engineering, biotechnology, or pharmaceutical sciencebr Must have experience in each of the following experience may be gained concurrentlybr Authoring and contributing to delivering CMC submission documents of development and marketed products biological, oligonucleotide, or chemical entities

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

2021-05-24

SWA Job Order End Date

2021-06-28

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-05-30

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-06

Employer Website From Date

2021-05-24

Employer Website To Date

2021-06-08

Professional Organization Ad From Date

2022-01-01 10:54:56

Professional Organization Advertisement To Date

2022-01-01 10:54:56

Job Search Website From Date

2021-05-25

Job Search Website To Date

2021-06-08

Employee Referral Program From Date

2021-05-24

Employee Referral Program To Date

2021-06-08

Local Ethnic Paper From Date

2022-01-01 10:54:56

Local Ethnic Paper To Date

2022-01-01 10:54:56

Radio/TV Ad From Date

2022-01-01 10:54:56

Radio/TV Ad To Date

2022-01-01 10:54:56

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 AND HEALTH POLICY

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

MCPHS UNIVERSITY

Foreign Worker Education Institution Address 1

179 LONGWOOD AVE.

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

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

Sophia Rossi

Preparer Title

Associate

Preparer Email

srteam@bal.com

Employer Information Declaration Name

Cassie Ramos

Employer Information Declaration Title

Lead Global Mobility Partner Immigration