Fiscal Year

2023

Case Number

A-22042-10344

Case Status

Certified

Received Date

2022-05-23

Decision Date

2023-02-10

Refile

N

Original File Date

2023-01-01 08:07:42

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTRAZENECA PHARMACEUTICALS LP

Employer Name Slug

astrazeneca-pharmaceuticals-lp

Employer Address 1

1800 CONCORD PIKE

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19897

Employer Phone

302-886-3000

Employer Number of Employees

83100

Employer Year Commenced Business

1966

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Echeverri Adriana

Employer Contact Address 1

One MedImmune Way

Employer Contact Address 2

Employer Contact City

Gaithersburg

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20878

Employer Contact Phone

301-398-0209

Employer Contact Email

adriana.echeverri@astrazeneca.com

Agent Attorney Name

Hyla K Rosenberg

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

svialva@fragomen.com

PW Track Number

P10021259587774

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

130291.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-03-17

PW Expiration Date

2022-06-30

Wage Offer From

130291.00

Wage Offer To

0.00

Average Salary

130291.00

Wage Unit of Pay

Year

Worksite Address 1

One MedImmune Way

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Manager, Regulatory Publishing

Job Title Slug

manager-regulatory-publishing

Minimum Education

Bachelor's

Major Field of Study

Regulatory Affairs, Life Science, Engineering (any), Technology or a related field

Required Training

N

Required Experience

Y

Required Experience Months

36

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

36

Accept Alternative Job Title

Regulatory Operations Specialist or a related position

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have a Bachelors degree or foreign equivalent in Regulatory Affairs, Life Science, Engineering any, Technology or a related field plus three 3 years of experience in the position offered, as a Regulatory Operations Specialist, or a related position. Must have three 3 years of experience in the pharmaceutical andor medical industry in each of the following Validating applications within a regulated environment; Drug developmentbr process, product lifecycle and formatting regulatory submissions; Utilizing regulatory publishing tools including eCTDXPress, FirstDoc, and ISIToolBox; Providing publishing technical expertise to address eCTD technical issues impacting global health authority regulatory submissions; Developing business requirements, test methodologies and training plans forbr regulatory system upgrade projects; Providing document publishing expertise to crossfunctional teams to ensure documents meet the health authorities submission ready standard requirements; Managing delivery and publishing of complex deliverables including clinical and nonclinical datasets, electronic case report forms, and electrocardiography forms; Addressing issues related to regulatory submissions and document publishing through ServiceNow ticketing system including system performance, functionality, health authority regulatory requirements, and user trainings; Driving and implementing publishing methodologies for the efficient transfer of regulatory information during external collaborations, mergers andbr acquisitions; and Analyzing changing health authority regulatory requirements and new collaborations between health authorities, and implementing strategic changes to internal publishing tools and processes.

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

2022-01-04

SWA Job Order End Date

2022-02-07

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2022-01-09

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-01-16

Employer Website From Date

2021-12-22

Employer Website To Date

2022-03-21

Professional Organization Ad From Date

2023-01-01 08:07:42

Professional Organization Advertisement To Date

2023-01-01 08:07:42

Job Search Website From Date

2022-01-09

Job Search Website To Date

2022-01-23

Employee Referral Program From Date

2023-01-01 08:07:42

Employee Referral Program To Date

2023-01-01 08:07:42

Local Ethnic Paper From Date

2022-01-12

Local Ethnic Paper To Date

2022-01-12

Radio/TV Ad From Date

2023-01-01 08:07:42

Radio/TV Ad To Date

2023-01-01 08:07:42

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

Bachelor's

Foreign Worker Information: Major

MECHANICAL ENGINEERING US EQUIV

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

KL UNIVERSITY

Foreign Worker Education Institution Address 1

GREEN FIELDS

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

VADDESWARAM

Foreign Worker Education Institution State/Province

ANDHRA PRADESH

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

522502

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hyla K Rosenberg

Preparer Title

Partner

Preparer Email

svialva@fragomen.com

Employer Information Declaration Name

Adriana Echeverri

Employer Information Declaration Title

International Experiences, Regional Lead NA