ASTRAZENECA PHARMACEUTICALS LP

Manager, Regulatory Publishing

A-22230-07925 H-1B 2023 Certified

Salary

$74,880

Visa Type

H-1B

Job Title

Manager, Regulatory Publishing

Employee's Citizenship

INDIA

Graduate School

NORTHEASTERN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22230-07925

Case Status Certified

Received Date 2022-11-08

Decision Date 2023-09-28

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name ASTRAZENECA PHARMACEUTICALS LP

Employer Address_Line 1 1800 CONCORD PIKE

Employer Address_Line 2 -

Employer City WILMINGTON

State -

Employer State/ Province DELAWARE

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 19897

Employer Phone No. 302-886-3000

Employer Phone Extent No. -

Total Number of Employees 83100

Employer Year of Commenced 1966

NAICS Code 32541

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Echeverri Adriana

Employer Contact Address Line1 One MedImmune Way

Employer Contact Address Line2 -

Employer Contact City Gaithersburg

Employer Contact State/ Provice MARYLAND

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 20878

Employer Contact Phone 301-398-0209

Employer Contact Email adriana.echeverri@astrazeneca.com

Attorney

11 fields

Agent/ Attorney Name Hyla K Rosenberg

Agent/ Attorney Firm Name Fragomen, Del Rey, Bernsen Loewy, LLP

Agent/ Attorney Phone 2126888555

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 1400 Broadway

Agent/ Attorney Address Line 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

Position Info

89 fields

Prevailing Wage Track Number P10021252574106

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Regulatory Affairs Specialist

Prevailing Wage Skill Level Level II

Prevailing Wage 74880

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-03-11

Prevailing Wage Expiration Date 2022-06-30

Wage Offer From 111999

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 101 Orchard Ridge Drive

Worksite Address Line 2 -

Worksite City Gaithersburg

Worksite State MARYLAND

Worksite Postal Code 20878

Job Title Manager, Regulatory Publishing

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Regulatory Affairs, Technology or a related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 36

Accept Alternate Field of Study N

Accept Alternate Major -

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 36

Accept Alternate Job Title Regulatory Affairs Associate or a related role in the IT healthcare or pharmaceutical sector

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Must have a Bachelors degree or foreign equivalent in Regulatory Affairs, Technology or a related field of study plus three 3 years of experience in offered role, as a Regulatory Affairs Associate or a related role in the IT healthcare or pharamaceutical sector. Employer will accept a Masters degree in a stated field in lieu of Bachelors. Employer will accept pre or post Masters degree experience. Must possess at least three 3 years of experience within the IT healthcare or pharmaceutical sector with Driving major drug submission and IT enablement projects across functional project teams; Change Request Management of Regulatory Information Management Systems including analyzing system requirements, reviewing use casesbr and system test scripts, developing User Acceptance Testing UAT and Operational Qualification OQ test scripts, managing communication plans and risk logs and supporting post implementation project needs; Developing Regulatory Submission methodologies through analysis of eCTD v4.0, Project Orbis, RTOR, and Brexit; Developing Submission Publishing internal and external training methodologies; Managing regulatory submissions for medical devices and combination products; and Publishing standards for Case Report Forms CRFsand engaging with Programming to manage datasets and adjudication packages prior to submission publishing.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-06-17

Job Oder End Date 2022-07-25

Sunday Edition Newspaper Y

First Newspaper Name The Washington Post

First Advertisement Start Date 2022-07-24

Second Newspaper Name The Washington Post

Second Advertisement Type Newspaper

Second Ad Start Date 2022-07-31

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-06-07

Employer Website to Date 2022-09-16

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-07-24

Job Search Website to Date 2022-08-07

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date 2022-07-20

Employee Referral Program to Date 2022-08-10

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-07-27

Local Ethnic Newspaper to Date 2022-07-27

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major REGULATORY AFFAIRS

Year of Compelted Education 2016

Foreign Worker Istitution of Eduation NORTHEASTERN UNIVERSITY

Foreign Worker Education Instution Address Line 1 360 HUNTINGTON AVE

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City BOSTON

Foreign Worker Educatution Institution State MA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 2115

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay 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 Declaration Title International Experiences, Regional Lead NA