Fiscal Year

2021

Case Number

A-20238-91702

Case Status

Certified

Received Date

2020-09-24

Decision Date

2021-05-05

Refile

N

Original File Date

2021-01-01 09:20:09

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SANDOZ, INC.

Employer Name Slug

sandoz-inc

Employer Address 1

100 COLLEGE ROAD WEST

Employer Address 2

Employer City

PRINCETON

Employer City Slug

princeton

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8540

Employer Phone

609-627-8500

Employer Number of Employees

104000

Employer Year Commenced Business

2003

NAICS Code

541710

FW Ownership Interest

N

Employer Contact Name

Bona Kwak

Employer Contact Address 1

One Health Plaza

Employer Contact Address 2

Employer Contact City

East Hanover

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7936

Employer Contact Phone

(678) 467-2958

Employer Contact Email

Bona.Kwak@novartis.com

Agent Attorney Name

Cole F Heyer

Agent Attorney Firm Name

Greeberg Traurig, LLP

Agent Attorney Phone

(678) 553-2117

Agent Attorney Address 1

3333 Piedmont Road NE

Agent Attorney Address 2

Suite 2500

Agent Attorney City

Atlanta

Agent Attorney State/Province

GEORGIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

30305

Agent Attorney Email

novartis@gtlaw.com

PW Track Number

P10019345192787

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

160306.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-03-26

PW Expiration Date

2020-06-30

Wage Offer From

160306.00

Wage Offer To

0.00

Average Salary

160306.00

Wage Unit of Pay

Year

Worksite Address 1

100 College Road West

Worksite Address 2

Worksite City

Princeton

Worksite City Slug

princeton

Worksite State

NEW JERSEY

Worksite Postal Code

8540

Job Title

Regulatory Affairs Advisor

Job Title Slug

regulatory-affairs-advisor

Minimum Education

Master's

Major Field of Study

Clinical Research, Regulatory Affairs, Pharmaceuticals, Business Management, or related field

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

7

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Related Position

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Primary Requirementsbr br Masters degree in Clinical Research, Regulatory Affairs, Pharmaceuticals, Business Management, or related field; and 5 years of experience in the job offered or related field. 5 years of experience with the following Pharmaceuticalbiotechnology industry; requirements for WRT submission in USA or EU drug developmentlaws. global regulations and filings pertaining to clinical, CMC, commercial, medical and IP needs; critical evaluation of emerging requirementsguidelines and product LCM; leading US FDA or EMA, interactions meetings negotiations and scientificregulatory input on PKPD and safetyefficacy studies and to crossfunctional global project teams; leading preparation, compilation and submission of high quality dossiers including preINDs, meeting requests, PSPs, INDs, SPAs, NDAsBLAs, amendments supplements PMRC fulfillment and annual reportsother compliance reports for complex sterile injectables and drugdevice combination products; ability to formulate and facilitate regulatory strategy to support development and approval efforts for assigned projects complex projects in a multicultural matrix setup within biopharmaceutical industry; identifying gaps and tradeoffs; WRT quality of submission documents or review timelines mitigate risks manage issues including aligning with stakeholders and line functions.br br Travel at least 2025, Domestic and Internationally.br br Alternative Requirementsbr br Bachelors degree in Clinical Research, Regulatory Affairs, Business Management, or related field and 7 years of experience in the job offered or related field. 7 years of experience with the following Pharmaceuticalbiotechnology industry; requirements for WRT submission in USA or EU drug developmentlaws. global regulations and filings pertaining to clinical, CMC, commercial. medical and IP needs; critical evaluation of emerging requirementsguidelines and product LCM; leading US FDA or EMA, interactions meetings negotiations and scientificregulatory input on PKPD and safetyefficacy studies and to crossfunctional global project teams; leading preparation compilation and submission of high quality dossiers including preINDs meeting requests PSPs, INDs, SPAs, NDAsBLAs, amendments supplements PMRC fulfillment and annual reportsother compliance reports for complex sterile injectables and drugdevice combination products; ability to formulate and facilitate regulatory strategy to support development and approval efforts for assigned projects complex projects in a multicultural matrix setup within biopharmaceutical industry; identifying gaps and tradeoffs; WRT quality of submission documents or review timelines mitigate risks manage issues including aligning with stakeholders and line functions.br br Travel at least 2025, Domestic and Internationally.

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

2020-06-22

SWA Job Order End Date

2020-07-22

Sunday Edition Newspaper

Y

First Newspaper Name

The Times

First Advertisement Start Date

2020-07-19

Second Newspaper Ad Name

The Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-26

Employer Website From Date

2021-01-01 09:20:09

Employer Website To Date

2021-01-01 09:20:09

Professional Organization Ad From Date

2021-01-01 09:20:09

Professional Organization Advertisement To Date

2021-01-01 09:20:09

Job Search Website From Date

2020-07-20

Job Search Website To Date

2020-07-27

Employee Referral Program From Date

2021-01-01 09:20:09

Employee Referral Program To Date

2021-01-01 09:20:09

Local Ethnic Paper From Date

2020-07-22

Local Ethnic Paper To Date

2020-07-22

Radio/TV Ad From Date

2020-07-18

Radio/TV Ad To Date

2020-07-19

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

ENTERPRISE BUSINESS MANAGEMENT

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

STRATFORD UNIVERSITY

Foreign Worker Education Institution Address 1

7777 LEESBURG PIKE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

FALLS CHURCH

Foreign Worker Education Institution State/Province

VA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

22043

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Cole F Heyer

Preparer Title

Attorney

Preparer Email

novartis@gtlaw.com

Employer Information Declaration Name

Bona Kwak

Employer Information Declaration Title

Immigration Counsel