Fiscal Year

2020

Case Number

A-19218-40599

Case Status

Certified-Expired

Received Date

2019-08-23

Decision Date

2019-10-30

Refile

N

Original File Date

2020-01-01 07:47:28

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BEIGENE USA, INC

Employer Name Slug

beigene-usa-inc

Employer Address 1

2955 CAMPUS DRIVE, SUITE 200

Employer Address 2

Employer City

SAN MATEO

Employer City Slug

san-mateo

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94403

Employer Phone

4159159985

Employer Number of Employees

900

Employer Year Commenced Business

2010

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Rosie Mitchell

Employer Contact Address 1

2955 Campus Drive, Suite 200

Employer Contact Address 2

Employer Contact City

San Mateo

Employer Contact State/Province

CALIFORNIA CA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94403

Employer Contact Phone

4159159985

Employer Contact Email

rosie.mitchell@beigene.com

Agent Attorney Name

Lina Gomes

Agent Attorney Firm Name

Clark Lau LLC

Agent Attorney Phone

6172994200

Agent Attorney Address 1

1 Main Street

Agent Attorney Address 2

First Floor

Agent Attorney City

Cambridge

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2142

Agent Attorney Email

lgomes@clarklau.com

PW Track Number

P10019114391407

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

107058.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-08-08

PW Expiration Date

2020-06-30

Wage Offer From

243700.00

Wage Offer To

0.00

Average Salary

243700.00

Wage Unit of Pay

Year

Worksite Address 1

2929 Campus Drive

Worksite Address 2

Worksite City

San Mateo

Worksite City Slug

san-mateo

Worksite State

CALIFORNIA

Worksite Postal Code

94403

Job Title

Senior Director of Regulatory Affairs

Job Title Slug

senior-director-of-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

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

120

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Employer requires a Bachelors degree in Biology, Microbiology, Medicine, Pharmacology, or a closely related field.br br In addition, the employer requires the followingbr br 1. Ten 10 years of experience in a regulatory affairs management capacity within the pharmaceutical industry;br br 2. Demonstrated knowledge of US and international GCP regulations and current industry practices gained through seven 7 years of work experience;br br 3. Demonstrated ability to interpret and apply US and international GCP regulations and current industry practices to development projects and marketed product regulatory issues gained through seven 7 years ofbr work experience;br br 4. Demonstrated knowledge of oncology regulations gained through five 5 years of work experience;br br 5. Demonstrated ability in developing and implementing regulatory strategies in hematology malignancies gained through seven 7 years of work experience;br br 6. Demonstrated ability with interacting with regulatory authorities including FDA and EMA gained through seven 7 years of work experience;br br 7. Demonstrated ability to serve as a lead in handling regulatory affairs across two or more geographic areas gained through seven 7 years of work experience; andbr br 8. Demonstrable ability in managing regulatory affairs employees gained through five 5 years of work experience.br br All years of experience may be gained concurrently.br 15 domestic travel and 5 international travel required. Beneficiary is willing to meet travel requirement.

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

2019-05-20

SWA Job Order End Date

2019-06-24

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2019-06-02

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-09

Employer Website From Date

2020-01-01 07:47:28

Employer Website To Date

2020-01-01 07:47:28

Professional Organization Ad From Date

2020-01-01 07:47:28

Professional Organization Advertisement To Date

2020-01-01 07:47:28

Job Search Website From Date

2019-05-13

Job Search Website To Date

2019-06-07

Employee Referral Program From Date

2020-01-01 07:47:28

Employee Referral Program To Date

2020-01-01 07:47:28

Local Ethnic Paper From Date

2019-07-19

Local Ethnic Paper To Date

2019-07-19

Radio/TV Ad From Date

2019-07-29

Radio/TV Ad To Date

2019-07-29

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CANADA

Foreign Worker Birth Country

CANADA

Class of Admission

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

BIOLOGICAL SCIENCES MICROBIOLOGY

Foreign Worker Years of Education Completed

1994

Foreign Worker Institution of Education

UNIVERSITY OF MONTREAL

Foreign Worker Education Institution Address 1

2900 EDOUARD MONTPETIT BOULEVARD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MONTREAL

Foreign Worker Education Institution State/Province

QUEBEC

Foreign Worker Education Institution Country

CANADA

Foreign Worker Education Institution Postal Code

H3T 1J4

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

Blair Dugan

Employer Information Declaration Title

Director, Human Resources