BAYER U.S. LLC

Senior Regulatory Affairs Submission Specialist

A-23041-00286 H-1B 2023 Withdrawn

Salary

$93,267

Visa Type

H-1B

Job Title

Senior Regulatory Affairs Submission Specialist

Employee's Citizenship

INDIA

Graduate School

CENTRAL MICHIGAN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-23041-00286

Case Status Withdrawn

Received Date 2023-04-12

Decision Date 2023-05-19

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 BAYER U.S. LLC

Employer Address_Line 1 100 BAYER BOULEVARD

Employer Address_Line 2 -

Employer City WHIPPANY

State -

Employer State/ Province NEW JERSEY

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 7981

Employer Phone No. 412-777-2375

Employer Phone Extent No. -

Total Number of Employees 15800

Employer Year of Commenced 2008

NAICS Code 325411

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Alex Greenberg

Employer Contact Address Line1 800 N. Lindbergh Blvd.

Employer Contact Address Line2 -

Employer Contact City St. Louis

Employer Contact State/ Provice MISSOURI

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 63167

Employer Contact Phone 3142439968

Employer Contact Email alex.greenberg1@bayer.com

Attorney

11 fields

Agent/ Attorney Name Alexander R Castrodale

Agent/ Attorney Firm Name Dentons Cohen Grigsby P.C.

Agent/ Attorney Phone (412) 297-4712

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 625 LIBERTY AVE

Agent/ Attorney Address Line 2 5th Floor

Agent/ Attorney City PITTSBURGH

Agent/ Attorney State/ Province PENNSYLVANIA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 15222

Agent/ Attorney Email alex.castrodale@dentons.com

Position Info

89 fields

Prevailing Wage Track Number P10022148222720

Prevailing Wage SOC Code 13-1041.07

Prevailing Wage SOC Title Regulatory Affairs Specialists

Prevailing Wage Skill Level Level III

Prevailing Wage 93267

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2023-01-18

Prevailing Wage Expiration Date 2023-06-30

Wage Offer From 107894

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 100 Bayer Boulevard

Worksite Address Line 2 -

Worksite City Whippany

Worksite State NEW JERSEY

Worksite Postal Code 7981

Job Title Senior Regulatory Affairs Submission Specialist

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Business Administration, Healthcare Administration, or a related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

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 Related position in the pharmaceutical industryregulatory affairs.

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills Must also have any experience with or knowledge of i electronic datadocument management, project management, computer systems or publishing software support, electronic document publishing, andor regulatory affairs; ii drug development process and relevant Standard Operating Procedures with an understanding of federal regulations, international standards e.g. ICH, and regulatory guidelines as they pertain to the development and filing of esubmissions; iii interpreting implications of regulations, applying them to daily operations, and responding appropriately to questions from peers and cross functional professional staff; iv word processing, document management, and desktop publishing software packages, including handson knowledge of various document types, authoring tools, and file formats MS office templates, PDF file rendering, SAS programtransport files, XML program code, etc.; v document management or electronic publishing tools; vi eCTD technical and validation requirements, as per ICH, FDA, EMA guidance, for publishing dossiers for the registration and lifecycle maintenance of medicinal products; vii publishing Study Data Standards Datasets according to the US FDA requirements and technical validation criteria; viii publishing Advertising and Promotional Materials in eCTD format; ix using eCTD publishing tools, preferably docubridge, and electronic document management systems; x evaluating and validating new software functionality and ITsystems used in the electronic submission process in order to keep up with evolving Health Authority regulations as well as for process improvement and efficiency initiatives; and xi training on the submission specialist publishing tasks and document authoring and workflow processes.br br Experience can be concurrent.br br This position is remote within the United States, but travel to Bayers Whippany, NJ, office for meetings or projects may be required. Associated travel expenses will be the employees responsibility.br br Note Since there is no experience required in H.6 the Kellogg language is not required.

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 2022-10-19

Job Oder End Date 2022-11-23

Sunday Edition Newspaper Y

First Newspaper Name The StarLedger

First Advertisement Start Date 2022-10-16

Second Newspaper Name The StarLedger

Second Advertisement Type Newspaper

Second Ad Start Date 2022-10-23

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-10-19

Employer Website to Date 2022-11-23

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-10-16

Job Search Website to Date 2022-10-28

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-10-19

Local Ethnic Newspaper to Date 2022-10-19

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 HEALTH SERVICES ADMINISTRATION

Year of Compelted Education 2016

Foreign Worker Istitution of Eduation CENTRAL MICHIGAN UNIVERSITY

Foreign Worker Education Instution Address Line 1 1200 S FRANKLIN STREET

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City MOUNT PLEASANT

Foreign Worker Educatution Institution State MI

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 48859

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

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 Alexander R Castrodale

Preparer Title Attorney

Preparer Email alex.castrodale@dentons.com

Employer Information Declaration Name Alex Greenberg

Employer Declaration Title Senior Immigration Specialist