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Case Number: A-20189-73506

Fiscal year: 2021

Fiscal Year

2021

Case Number

A-20189-73506

Case Status

Certified

Received Date

2020-09-04

Decision Date

2021-04-16

Refile

N

Original File Date

2021-01-01 09:13:42

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BIOMARIN PHARMACEUTICAL, INC.

Employer Name Slug

biomarin-pharmaceutical-inc

Employer Address 1

105 DIGITAL DRIVE

Employer Address 2

Employer City

NOVATO

Employer City Slug

novato

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94949

Employer Phone

415-506-6700

Employer Number of Employees

2157

Employer Year Commenced Business

1997

NAICS Code

325414

FW Ownership Interest

N

Employer Contact Name

Liliane Cromer

Employer Contact Address 1

105 Digital Drive

Employer Contact Address 2

Employer Contact City

Novato

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94949

Employer Contact Phone

415-455-7838

Employer Contact Email

liliane.cromer@bmrn.com

Agent Attorney Name

Melissa B Harms

Agent Attorney Firm Name

Law Office of Melissa Harms

Agent Attorney Phone

415-945-9600

Agent Attorney Address 1

700 Larkspur Landing Circle

Agent Attorney Address 2

Suite 199

Agent Attorney City

Larkspur

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94939

Agent Attorney Email

mharms@harms-law.com

PW Track Number

P10020041310569

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level III

PW Wage

165610.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-01

PW Expiration Date

2020-07-30

Wage Offer From

165610.00

Wage Offer To

0.00

Average Salary

165610.00

Wage Unit of Pay

Year

Worksite Address 1

770 Lindaro Street

Worksite Address 2

Worksite City

San Rafael

Worksite City Slug

san-rafael

Worksite State

CALIFORNIA

Worksite Postal Code

94901

Job Title

Manager, Regulatory Operations

Job Title Slug

manager-regulatory-operations

Minimum Education

Bachelor's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

Y

Required Experience Months

48

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Information Technology or a closely related field

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

48

Accept Alternative Job Title

Regulatory Operations Assoc, Reg. Affairs Assoc, Reg. Affairs Publisher, Submissions Pub or rel occ

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

4 years of experience in the job offered, as a Regulatory Operations Associate, Regulatory Affairs Associate, Regulatory Affairs Publisher, Submissions Publisher or in a related occupation.br br Candidates must possess any experience or education in the followingbr Experience using an electronic document management system eDMS to upload documentation, complete metadata, utilize workflows, archive per process.br Experience publishing using eCTD Publishing Systems, including sequence and assembly creation, assignment of documentation, proper assignment of metadata and tagging, proper placement of documentation, rendering to PDF, adding any required special sheets, and publishing to eCTD.br Experience formatting, publishing, and archiving electronic submissions, including initial INDs, NDAs, Annual Reports, Supplements specifically eCTD, for US, Europe, and Canada.br Experience using eCTD validation tools including GlobalSubmit, Lorenz eValidator, and Pragmatic Lite for SPL.

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

2020-05-27

SWA Job Order End Date

2020-07-02

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2020-06-07

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-06-14

Employer Website From Date

2021-01-01 09:13:42

Employer Website To Date

2021-01-01 09:13:42

Professional Organization Ad From Date

2021-01-01 09:13:42

Professional Organization Advertisement To Date

2021-01-01 09:13:42

Job Search Website From Date

2020-05-27

Job Search Website To Date

2020-07-02

Employee Referral Program From Date

2021-01-01 09:13:42

Employee Referral Program To Date

2021-01-01 09:13:42

Local Ethnic Paper From Date

2020-06-11

Local Ethnic Paper To Date

2020-06-18

Radio/TV Ad From Date

2021-01-01 09:13:42

Radio/TV Ad To Date

2021-01-01 09:13:42

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 FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2011

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

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

Melissa B Harms

Preparer Title

Attorney

Preparer Email

mharms@harms-law.com

Employer Information Declaration Name

Liliane Cromer

Employer Information Declaration Title

Director, HR