Fiscal Year

2022

Case Number

A-21306-66918

Case Status

Certified

Received Date

2021-11-30

Decision Date

2022-06-28

Refile

N

Original File Date

2022-01-01 11:40:30

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

PATH

Employer Name Slug

path

Employer Address 1

2201 WESTLAKE AVENUE

Employer Address 2

SUITE 200

Employer City

SEATTLE

Employer City Slug

seattle

Employer State

WASHINGTON

Employer State Slug

washington

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

98121

Employer Phone

2062853500

Employer Number of Employees

578

Employer Year Commenced Business

1977

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Lindsey Mollenholt

Employer Contact Address 1

2201 Westlake Avenue

Employer Contact Address 2

Suite 200

Employer Contact City

Seattle

Employer Contact State/Province

WASHINGTON

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

98121

Employer Contact Phone

206-285-3500

Employer Contact Email

lmollenholt@path.org

Agent Attorney Name

Felicia L Gittleman

Agent Attorney Firm Name

Cowan Miller Lederman

Agent Attorney Phone

2068769751

Agent Attorney Address 1

1000 Second Avenue

Agent Attorney Address 2

Suite 1620

Agent Attorney City

Seattle

Agent Attorney State/Province

WASHINGTON

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

98104

Agent Attorney Email

fgittleman@cmlseattle.com

PW Track Number

P10021063120114

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

134618.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-10-04

PW Expiration Date

2022-06-30

Wage Offer From

136872.00

Wage Offer To

198578.00

Average Salary

167725.00

Wage Unit of Pay

Year

Worksite Address 1

2201 Westlake Ave

Worksite Address 2

Suite 200

Worksite City

Seattle

Worksite City Slug

seattle

Worksite State

WASHINGTON

Worksite Postal Code

98121

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Bachelor's

Major Field of Study

Life Science, Health Science or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Life Science, Health Science or a 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

60

Accept Alternative Job Title

Any occupation with the skills in H.14.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

A Bachelors degree in Life Science, Health Science or a related field, or the foreign degree equivalent, plus five years of progressive, postbaccalaureate regulatory affairs experience relating to health products. The work experience must include five years of experience in the followingbr 1. Create and implement regulatory strategies for drug andor vaccine development, which ensure compliance with the guidelines and regulations of the national regulatory authorities responsible for oversight of drugs andor vaccines in the locations where the product will be manufactured, tested and licensed for sale;br 2. Plan and coordinate meetings and lead negotiations with national health authorities to seek agreement on the requirements necessary to secure government approval of new health products;br 3. Utilize knowledge of applicable regulatory requirements, procedures and policies to prepare regulatory documents including applications for clinical trial approvals, applications for marketing authorizations and requests for meetings, briefing documents to support meetings, minutes of meetings with national regulatory authorities for submission to national regulatory authorities responsible for the oversight of drugs andor vaccines; andbr 4. Provide project management and oversight to ensure that the submissions are filed according to the required timelines defined by the national regulatory authorities responsible for the oversight of drugs andor vaccines.br br 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

2021-09-22

SWA Job Order End Date

2021-10-25

Sunday Edition Newspaper

Y

First Newspaper Name

The Seattle Times

First Advertisement Start Date

2021-09-26

Second Newspaper Ad Name

The Seattle Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-10-03

Employer Website From Date

2022-01-01 11:40:30

Employer Website To Date

2022-01-01 11:40:30

Professional Organization Ad From Date

2022-01-01 11:40:30

Professional Organization Advertisement To Date

2022-01-01 11:40:30

Job Search Website From Date

2021-09-22

Job Search Website To Date

2021-10-04

Employee Referral Program From Date

2022-01-01 11:40:30

Employee Referral Program To Date

2022-01-01 11:40:30

Local Ethnic Paper From Date

2021-09-29

Local Ethnic Paper To Date

2021-09-29

Radio/TV Ad From Date

2021-09-29

Radio/TV Ad To Date

2021-09-29

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

HEALTH SCIENCES

Foreign Worker Years of Education Completed

2004

Foreign Worker Institution of Education

UNIVERSITY OF WESTERN ONTARIO NOW WESTERN UNIVERSITY

Foreign Worker Education Institution Address 1

1151 RICHMOND STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LONDON

Foreign Worker Education Institution State/Province

ONTARIO

Foreign Worker Education Institution Country

CANADA

Foreign Worker Education Institution Postal Code

N6A 3K7

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Felicia L Gittleman

Preparer Title

Attorney

Preparer Email

fgittleman@cmlseattle.com

Employer Information Declaration Name

Lindsey Mollenholt

Employer Information Declaration Title

HR Director