Fiscal Year

2023

Case Number

A-21351-87750

Case Status

Certified

Received Date

2022-03-01

Decision Date

2022-11-21

Refile

N

Original File Date

2023-01-01 18:09:21

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

76100

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

P10021165396443

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level III

PW Wage

90917.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-11-19

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

101 Orchard Ridge Drive

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Associate Director, Global Regulatory Operations

Job Title Slug

associate-director-global-regulatory-operations

Minimum Education

Bachelor's

Major Field of Study

Regulatory Affairs, Pharmacy, Life Science, 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 Publisher or in a related role

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must possess a Bachelors degree or foreign equivalent in Regulatory Affairs, Pharmacy, Life Science, Technology or a related field plus three 3 years of experience in the role offered, as a Regulatory Publisher, or in a related role. Must have at least three 3 years of experience with all the following in the pharmaceutical andor drug development industry System administration for validated applications within a regulated environment; Document and submission publishing tools, including eCTDXpress, FirstDoc, and ISIToolBox; Driving major drug submissions and IT enablement projects by providing regulatory publishing and project management expertise to the core crossfunctional project teams; Change Request Management of Regulatory Information Management Systems, including analyzing system requirements, reviewing use cases and system test scripts, developing User Acceptance Testing and Operational Qualification test scripts, managing communication plans and risk logs, and supporting postimplementation project needs; Identifying potential areas where innovation is possible and developing project proposals for implementation of these ideas; Developing Submission Publishing internal and external training and effective training methodologies; Developing innovative Regulatory Submission methodologies through a thorough analysis of new initiatives released by health agencies, including Ectd v4.0, Project Orbis, RTOR, andor Brexit; Providing regulatory publishing expertise and guidance for regulatory submissions to Investigational New Drugs and New Drug Applications including original applications, amendments, safety reports, annual reports, presubmission and general correspondence; Addressing daily publishing service tickets across regulatory publishing tools; Managing and interpreting changing regulatory submission requirements across different health agencies, including US FDA, EMA, UK andor other emerging markets, by engaging with market desk contacts, participating in external forum discussions and reviewing agency guidance; and Driving operational excellence by providing means to improve publishing timelines for accelerated submissions. Employer will accept a Masters in a stated field in lieu of a Bachelors degree. Any suitable combination of education, training or experience is acceptable.

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

2021-11-18

SWA Job Order End Date

2021-12-23

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2021-12-05

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-12

Employer Website From Date

2021-11-11

Employer Website To Date

2022-01-25

Professional Organization Ad From Date

2023-01-01 18:09:21

Professional Organization Advertisement To Date

2023-01-01 18:09:21

Job Search Website From Date

2021-12-05

Job Search Website To Date

2021-12-19

Employee Referral Program From Date

2021-11-11

Employee Referral Program To Date

2021-12-02

Local Ethnic Paper From Date

2021-12-08

Local Ethnic Paper To Date

2021-12-08

Radio/TV Ad From Date

2023-01-01 18:09:21

Radio/TV Ad To Date

2023-01-01 18:09:21

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

2013

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

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