Fiscal Year

2021

Case Number

A-20045-19573

Case Status

Certified-Expired

Received Date

2020-04-16

Decision Date

2021-03-25

Refile

N

Original File Date

2021-01-01 09:08:39

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EXELA PHARMA SCIENCES LLC

Employer Name Slug

exela-pharma-sciences-llc

Employer Address 1

1245 BLOWING ROCK BLVD

Employer Address 2

PO BOX 818

Employer City

LENOIR

Employer City Slug

lenoir

Employer State

NORTH CAROLINA

Employer State Slug

north-carolina

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

28645

Employer Phone

828 758 5474

Employer Number of Employees

260

Employer Year Commenced Business

2008

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Phanesh Koneru

Employer Contact Address 1

1245 Blowing Rock Blvd

Employer Contact Address 2

PO Box 818

Employer Contact City

Lenoir

Employer Contact State/Province

NORTH CAROLINA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

28645

Employer Contact Phone

828 758 5474 147

Employer Contact Email

phanesh@exela.us

Agent Attorney Name

Ravi Mannam

Agent Attorney Firm Name

Mannam Associates, LLC

Agent Attorney Phone

877-596-1761

Agent Attorney Address 1

3651 Peachtree Parkway, Suite E360

Agent Attorney Address 2

Agent Attorney City

Suwanee

Agent Attorney State/Province

GEORGIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

30024

Agent Attorney Email

lawxpert@yahoo.com

PW Track Number

P10019289091676

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists Compliance Officers

PW Skill Level

Level II

PW Wage

43659.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-02-14

PW Expiration Date

2020-06-30

Wage Offer From

62500.00

Wage Offer To

0.00

Average Salary

62500.00

Wage Unit of Pay

Year

Worksite Address 1

1245 Blowing Rock Blvd.

Worksite Address 2

Worksite City

Lenoir

Worksite City Slug

lenoir

Worksite State

NORTH CAROLINA

Worksite Postal Code

28645

Job Title

Regulatory Affairs Specialist

Job Title Slug

regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Master’s in Drug Regulatory Affairs, a Bachelor’s in Pharmacy

Required Training

N

Required Experience

N

Required Experience Months

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

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

OTHER REQUIREMENTSbr br Masters degree or foreign equiv. in Drug Regulatory Affairs, a Bachelors degree or foreign equiv. in Pharmacy and 1 year experience in Drug Regulatory Affairs.br br COURSEWORKbr br Basic Pharmaceutics, Drug Regulatory Affairs, FDA Regulation of OvertheCounter Drugs, Medical Devices Dietary Supplements, CMC Regulatory Affairs, Principles Practices of Regulatory Compliance Enforcement, Pharmaceutical Labeling, Advertising Promotion, International Drug Regulatory Affairs, Biostatistics, The American Pharmaceutical Industry, Patent Law Pharmaceutical Industry, Mechanics of Preparing INDs NDAs, Pharmaceutical Chemistry PharmaceuticalOrganicChemistry, Pharmaceutical Mathematics, Pharmaceutics Dispensing HospitalPharmacy, Pharmaceutics GeneralPharmacy, PharmacologyI, Environment Studies Qual, Pharmaceutical Chemistry PhysicalChemistry, Pharmaceutical Chemistry Pharmaceutical AnalyticalI, Pharmaceutical Chemistry PharmaceuticalBiochemistry, Pharmaceutics Pharmaceutical EngineeringDrawing, Pharmacognosy II, Pharmaceutical Management Psychology, Pharmaceutical Chemistry MedicinalChemistryI, Pharmaceutics PHENGG2, Pharmaceutics PHA. TECHI, Pharmaceutics ForensicPharmacy, Pharmacology PHA. Animal Biotech, Pharmaceutical Chem MedicinalChemistryII, Pharmaceutical Chem PHA. AnalyticalII, Pharmaceutics PHARM. TECH II, Pharmaceutics PHAPackaging Tech, Pharmaceutics BioPharma Pharmacokinetics, Pharmacognosy Pharm. Plant Biotech.br br ALIEN BENEFICIARY SATISFIES EMPLOYERS REQUIREMENTS FOR THIS POSITIONbr br Alien Beneficiary, Ms. Jaswinder Kaur, satisfies all education, experience coursework requirements for this position prior to her hire at petitioner employer, Exela Pharma Sciences, LLC.br br Ms. Jaswinder Kaur satisfies the education coursework requirements for this position through her Masters degree in Drug Regulatory Affairs from Long Island University, USA May 2015, and her Bachelors degree in Pharmacy from Pandit Bhagwat Dayal Sharma University of Health Science, India May 2012. Through her Masters degree coursework, Ms. Kaur completed the required coursework in the following Basic Pharmaceutics, Drug Regulatory Affairs, FDA Regulation of OvertheCounter Drugs, Medical Devices Dietary Supplements, CMC Regulatory Affairs, Principles Practices of Regulatory Compliance Enforcement, Pharmaceutical Labeling, Advertising Promotion, International Drug Regulatory Affairs, Biostatistics, The American Pharmaceutical Industry, Patent Law Pharmaceutical Industry, Mechanics of Preparing INDs NDAs. Through her Bachelors degree coursework, Ms. Kaur completed the required coursework in the following Pharmaceutical Chemistry PharmaceuticalOrganicChemistry, Pharmaceutical Mathematics, Pharmaceutics Dispensing HospitalPharmacy, Pharmaceutics GeneralPharmacy, PharmacologyI, Environment Studies Qual, Pharmaceutical Chemistry PhysicalChemistry, Pharmaceutical Chemistry Pharmaceutical AnalyticalI, Pharmaceutical Chemistry PharmaceuticalBiochemistry, Pharmaceutics Pharmaceutical EngineeringDrawing, Pharmacognosy II, Pharmaceutical Management Psychology, Pharmaceutical Chemistry MedicinalChemistryI, Pharmaceutics PHENGG2, Pharmaceutics PHA. TECHI, Pharmaceutics ForensicPharmacy, Pharmacology PHA. Animal Biotech, Pharmaceutical Chem MedicinalChemistryII, Pharmaceutical Chem PHA. AnalyticalII, Pharmaceutics PHARM. TECH II, Pharmaceutics PHAPackaging Tech, Pharmaceutics BioPharma Pharmacokinetics, Pharmacognosy Pharm. Plant Biotech.br br Alien beneficiary satisfies the experience requirements listed at Part H, Line 14 through prior experience shown at Part K Alien Work Experience.br br To determine experience, employer does not consider job titles, but job duties as dispositive on this issue.

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

2019-10-20

SWA Job Order End Date

2020-01-20

Sunday Edition Newspaper

Y

First Newspaper Name

The Charlotte Observer

First Advertisement Start Date

2020-02-23

Second Newspaper Ad Name

The Charlotte Observer

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-03-01

Employer Website From Date

2019-10-29

Employer Website To Date

2019-12-12

Professional Organization Ad From Date

2021-01-01 09:08:39

Professional Organization Advertisement To Date

2021-01-01 09:08:39

Job Search Website From Date

2019-10-20

Job Search Website To Date

2020-01-20

Employee Referral Program From Date

2021-01-01 09:08:39

Employee Referral Program To Date

2021-01-01 09:08:39

Local Ethnic Paper From Date

2020-02-26

Local Ethnic Paper To Date

2020-02-26

Radio/TV Ad From Date

2020-03-11

Radio/TV Ad To Date

2020-03-11

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

DRUG REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY PLAZA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Ravi Mannam

Preparer Title

Attorney

Preparer Email

lawxpert@yahoo.com

Employer Information Declaration Name

Phanesh Koneru

Employer Information Declaration Title

President CEO