Case Details

Case info Company Info HR Info Attorney Position Info Employee Info
Case info
  • Data Publish Year :2022
  • Case Number:A-21312-69522
  • Case Status:Certified
  • Received Date:2021-12-13
  • Decision Date:2022-09-06
  • Refile:N
  • Original File Date:
  • Previous State Work Force Agency (SWA) Case Number Stete:
  • Schedule A or a Sheepherder Occupation :N
Company Info
  • Employer Name:Otsuka Pharmaceutical Development Commericalizat
  • Employer Address_Line 1:508 Carnegie Center Drive
  • Employer Address_Line 2:
  • Employer City :Princeton
  • State:
  • Employer State/ Province:NEW JERSEY
  • Employer Country:UNITED STATES OF AMERICA
  • Employer Postal Code:8540
  • Employer Phone No.:609-524-6788
  • Employer Phone Extent No.:
  • Total Number of Employees:466
  • Employer Year of Commenced :
  • NAICS Code:32541
  • Foreign Worker Ownership & Interest:N
HR Info
  • Employer Contact Name:Regina A Wheeler
  • Employer Contact Address Line1:508 Carnegie Center Drive
  • Employer Contact Address Line2:
  • Employer Contact City:Princeton
  • Employer Contact State/ Provice:NEW JERSEY
  • Employer Contact Country :UNITED STATES OF AMERICA
  • Employer Contact Post Code:8540
  • Employer Contact Phone:609-608-4558
  • Employer Contact Email:Regina.Wheeler@otsuka-us.com
Attorney
  • Agent/ Attorney Name:Sufen Zhang
  • Agent/ Attorney Firm Name:Miles Stockbridge
  • Agent/ Attorney Phone:410-385-3608
  • Agent/ Attorney Phone Ext.:
  • Agent/ Attorney Address Line 1:100 Light Street
  • Agent/ Attorney Address Line 2:
  • Agent/ Attorney City:Baltimore
  • Agent/ Attorney State/ Province:MARYLAND
  • Agent/ Attorney Country:UNITED STATES OF AMERICA
  • Agent/ Attorney Postal Code:21202
  • Agent/ Attorney Email:szhang@milesstockbridge.com
Position Info
  • Prevailing Wage Track Number:P10021046077282
  • Prevailing Wage SOC Code :13-1041
  • Prevailing Wage SOC Title :Compliance Officers
  • Prevailing Wage Skill Level:Level IV
  • Prevailing Wage:96450
  • Prevailing Wage Unit of Pay:Year
  • Prevailing Wage Source:OES
  • Prevailing Wage Other Source:
  • Prevailing Wage Determination Date :2021-07-06
  • Prevailing Wage Expiration Date :2022-06-30
  • Wage Offer From:96450
  • Wage Offer To:112229
  • Wage Offer Unit of Pay:Year
  • Workstie Address Line 1:508 Carnegie Center Drive
  • Worksite Address Line 2:
  • Worksite City :Princeton
  • Worksite State:NEW JERSEY
  • Worksite Postal Code:8540
  • Job Title:Senior Regulatory Operations Associate
  • Minimum Education:Bachelor's
  • Other Degree/ Diploma:
  • Major Field of Study:Pharmacy, Product Safety, Regulatory Affairs, or closely 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:48
  • Accept Alternate Job Title:Any position that provides the required experience.
  • Normal Requirements of Job Opportunity:Y
  • Required Foreign Language:N
  • Specific Skills: Bachelors degree, or foreign equivalent, in Pharmacy, Product Safety, Regulatory Affairs, or another closely related field.br br Four 4 years of related work experience to include the followingbr Regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving eCTD sequences.br FDAEMAHCSwiss Medic regulations and guidance for electronic and paper submissions.br Managing and producing timesensitive eCTD ready submissions and other document publishing deliverables.br Document Management Systems Documentum and publishing tools, Lorenz DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox.br NDAs New Drug Application and MAAs Marketing Authorization Application.
  • 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:2021-08-23
  • Job Oder End Date:2021-09-22
  • Sunday Edition Newspaper:Y
  • First Newspaper Name:The StarLedger
  • First Advertisement Start Date:2021-08-29
  • Second Newspaper Name:The StarLedger
  • Second Advertisement Type:Newspaper
  • Second Ad Start Date:2021-09-05
  • Job Fair From Date:
  • Job Fair to Date:
  • On Campus Recruiting from Date:
  • On Campus Recruiting to Date:
  • Employer Website from Date:2021-09-07
  • Employer Website to Date:2021-09-24
  • Pro. Org. Ad from Date:
  • Pro.Org. Ad to Date:
  • Job Search Website from Date:2021-08-30
  • Job Search Website to Date:2021-09-13
  • 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:2021-09-03
  • Local Ethnic Newspaper to Date:2021-09-03
  • 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
  • Foreign Worker Education:Master's
  • Foreign Worker Education Other:
  • Foreign Worker Major:REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES
  • Year of Compelted Education:2015
  • Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
  • Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVENUE
  • 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/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:Sufen Zhang
  • Preparer Title:Principal
  • Preparer Email :szhang@milesstockbridge.com
  • Employer Information Declaration Name:Regina A Wheeler
  • Employer Declaration Title:Manager, Mobility and Immigration Services
Back to Top

Contact Us : contact@iadapt.ca

Office Address : Social Innovation Hub Unit #290, 3553 31 St NW Calgary, AB, Canada T2L 2K7 (Please contact us in advance for visiting)