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