Fiscal Year

2023

Case Number

A-22028-04102

Case Status

Certified

Received Date

2022-02-09

Decision Date

2022-10-14

Refile

N

Original File Date

2023-01-01 18:18:06

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASCENTAGE PHARMA GROUP INC.

Employer Name Slug

ascentage-pharma-group-inc

Employer Address 1

800 KING FARM BOULEVARD

Employer Address 2

SUITE 300

Employer City

ROCKVILLE

Employer City Slug

rockville

Employer State

MARYLAND

Employer State Slug

maryland

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

20850

Employer Phone

301-520-8044

Employer Number of Employees

85

Employer Year Commenced Business

2009

NAICS Code

541710

FW Ownership Interest

N

Employer Contact Name

Jason Gilmore

Employer Contact Address 1

800 King Farm Boulevard

Employer Contact Address 2

Suite 300

Employer Contact City

Bethesda

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20850

Employer Contact Phone

301-520-8044

Employer Contact Email

jason.gilmore@ascentage.com

Agent Attorney Name

Clarissa C Upadhyay

Agent Attorney Firm Name

Trow Rahal, P.C.

Agent Attorney Phone

2025374830

Agent Attorney Address 1

3 Bethesda Metro Center

Agent Attorney Address 2

Suite 610

Agent Attorney City

Bethesda

Agent Attorney State/Province

MARYLAND

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

20814

Agent Attorney Email

clarissa@trowrahal.com

PW Track Number

P10021134315966

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level II

PW Wage

74880.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-10-27

PW Expiration Date

2022-06-30

Wage Offer From

150000.00

Wage Offer To

170000.00

Average Salary

160000.00

Wage Unit of Pay

Year

Worksite Address 1

800 King Farm Blvd., Suite 300

Worksite Address 2

Telecommuting permitted

Worksite City

Rockville

Worksite City Slug

rockville

Worksite State

MARYLAND

Worksite Postal Code

20850

Job Title

Sr. Regulatory Operations Manager

Job Title Slug

sr-regulatory-operations-manager

Minimum Education

Master's

Major Field of Study

Biology

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacology, Chemistry, 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

24

Accept Alternative Job Title

Job offered or a related regulatory affairs position implementing eCTD and document publishing tools

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have two 2 years of experience with each 1 Reviewing, compiling, publishing and filing eCTD submissions for INDs, NDAs, and SupplementsAmendments to FDA and other health authorities; 2 Implementing FDA eCTD specification standards for documents authored internally; 3 Identifying and implementing eCTD and document publishing tools for establishing regulatory operation within the company; 4 Managing multiple regulatory publishing activities for various application and submission types which are in various clinical development stages Phase I, II and III; 5 Leveraging systems such as Share Point, SAS tools, and Veeva systems for authoring and submitting regulatory documents as per health authority requirements.

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

2021-11-01

SWA Job Order End Date

2021-12-06

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2021-11-21

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-05

Employer Website From Date

2022-01-21

Employer Website To Date

2022-01-28

Professional Organization Ad From Date

2021-11-02

Professional Organization Advertisement To Date

2021-12-02

Job Search Website From Date

2021-11-02

Job Search Website To Date

2021-11-16

Employee Referral Program From Date

2023-01-01 18:18:06

Employee Referral Program To Date

2023-01-01 18:18:06

Local Ethnic Paper From Date

2023-01-01 18:18:06

Local Ethnic Paper To Date

2023-01-01 18:18:06

Radio/TV Ad From Date

2023-01-01 18:18:06

Radio/TV Ad To Date

2023-01-01 18:18:06

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

CHEMISTRY

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

WESTERN ILLINOIS UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY CIRCLE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MACOMB

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

61455

Foreign Worker Experience with Employer

N/A

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Clarissa C Upadhyay

Preparer Title

Attorney

Preparer Email

clarissa@trowrahal.com

Employer Information Declaration Name

Jason Gilmore

Employer Information Declaration Title

Senior Director of Human Resources