Fiscal Year

2023

Case Number

A-21173-05496

Case Status

Certified

Received Date

2022-06-17

Decision Date

2023-02-08

Refile

N

Original File Date

2023-01-01 08:08:26

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BEIGENE USA, INC

Employer Name Slug

beigene-usa-inc

Employer Address 1

55 CAMBRIDGE PARKWAY, SUITE 700W

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

781-801-1800

Employer Number of Employees

900

Employer Year Commenced Business

2015

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Amy E Nobriga

Employer Contact Address 1

1900 Powell St, Suite 500

Employer Contact Address 2

Employer Contact City

Emeryville

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94608

Employer Contact Phone

415-992-7715

Employer Contact Email

amy.nobriga@beigene.com

Agent Attorney Name

Lina Gomes

Agent Attorney Firm Name

Clark Lau LLC

Agent Attorney Phone

6172994200

Agent Attorney Address 1

155 Federal Street

Agent Attorney Address 2

Suite 400

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2110

Agent Attorney Email

lgomes@clarklau.com

PW Track Number

P10021204479570

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level IV

PW Wage

116355.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-01-07

PW Expiration Date

2022-06-30

Wage Offer From

130000.00

Wage Offer To

145000.00

Average Salary

137500.00

Wage Unit of Pay

Year

Worksite Address 1

1900 Powell Street, Suite 500

Worksite Address 2

Worksite City

Emeryville

Worksite City Slug

emeryville

Worksite State

CALIFORNIA

Worksite Postal Code

94608

Job Title

Manager, Regulatory Affairs

Job Title Slug

manager-regulatory-affairs

Minimum Education

Bachelor's

Major Field of Study

Biology, Biochem, Pharmacy, Regulatory Affairs, or closely rel

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Bachelors degree in Biology, Biochemistry, Pharmacy, Regulatory Affairs, or a closely related scientific field and at least five 5 years of work experience in the biotechnical or pharmaceutical industry.br br ORbr br Masters degree in Biology, Biochemistry, Pharmacy, Regulatory Affairs, or a closely related scientific field and at least three 3 years of experience in the biotechnical or pharmaceuticalbr industry.br br In addition the employer requiresbr 1. Minimum of two 2 years of work experience in a regulatory capacity.br 2. Demonstrated experience with CTDeCTD gained through at least two 2 years of work experience.br 3. Demonstrated experience and knowledge in preparation of INDs required and CTAs, and supportive amendments and supplements manufacturing, nonclinical, clinical gained throughbr at least two 2 years of work experience.br 4. Demonstrated experience with preparation and facilitating health authority interactions gained through two 2 years of work experience.br 5. Demonstrated planning and communication skills applied in regulatory and crossfunctional sub teams, and contract research organizations to execute regulatory filings, gained throughbr at least three 3 years of work experience.br 6. Demonstrated knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle gained through at least three 3 years of workbr experience.br All years of experience may be gained concurrently.

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

2022-01-19

SWA Job Order End Date

2022-02-28

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2022-01-30

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-02-06

Employer Website From Date

2022-01-19

Employer Website To Date

2022-01-31

Professional Organization Ad From Date

2023-01-01 08:08:26

Professional Organization Advertisement To Date

2023-01-01 08:08:26

Job Search Website From Date

2022-01-24

Job Search Website To Date

2022-02-08

Employee Referral Program From Date

2022-01-19

Employee Referral Program To Date

2022-01-31

Local Ethnic Paper From Date

2023-01-01 08:08:26

Local Ethnic Paper To Date

2023-01-01 08:08:26

Radio/TV Ad From Date

2023-01-01 08:08:26

Radio/TV Ad To Date

2023-01-01 08:08:26

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

TAIWAN

Foreign Worker Birth Country

TAIWAN

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOSCIENCE

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

KECK GRADUATE INSTITUTE OF APPLIED SCIENCES KGI

Foreign Worker Education Institution Address 1

535 WATSON DR.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CLAREMONT

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

91711

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Lina Gomes

Preparer Title

Attorney

Preparer Email

lgomes@clarklau.com

Employer Information Declaration Name

Amy Nobriga

Employer Information Declaration Title

Senior Manager, Global Mobility