Agent/ Attorney Address Line 1:2200 Pennsylvania Avenue NW
Agent/ Attorney Address Line 2:
Agent/ Attorney City:Washington
Agent/ Attorney State/ Province:DISTRICT OF COLUMBIA
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:20037
Agent/ Attorney Email:iband@huntonak.com
Position Info
Prevailing Wage Track Number:P10021077156751
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
Prevailing Wage Skill Level:Level II
Prevailing Wage:94952
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-08-18
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:95000
Wage Offer To:165000
Wage Offer Unit of Pay:Year
Workstie Address Line 1:1 Discovery Drive
Worksite Address Line 2:
Worksite City :Swiftwater
Worksite State:PENNSYLVANIA
Worksite Postal Code:18370
Job Title:Regulatory CMC Vaccines Manager
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Regulatory Affairs
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :12
Accept Alternate Field of Study:Y
Accept Alternate Major:Biological sciences or a related field
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:2
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:12
Accept Alternate Job Title:Related position
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Experience must include 1 year in regulatory affairs authoring modules 2 and 3 of the Common Technical Document CTD; Chemistry Manufacturing and Controls CMC; North American, European, and international regulations and guidelines related to biological products; serving as a regulatory representative on crossfunctional project teams working on a developmental biological product intended for international license; and microbiology, immunology, virology, or bacteriology.br br Will also accept a Bachelors degree in biological sciences or a related field and 2 years of regulatory affairs experience, including 1 year in regulatory affairs authoring modules 2 and 3 of the Common Technical Document CTD; Chemistry Manufacturing and Controls CMC; North American, European, and international regulations and guidelines related to biological products; serving as a regulatory representative on crossfunctional project teams working on a developmental biological product intended for international license; and microbiology, immunology, virology, or bacteriology in lieu of a masters degree and 1 year of experience.br br Will accept an suitable combination of education and experience, but no less than a bachelors degree and 2 years of experience.
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:2021-10-12
Job Oder End Date:2021-11-11
Sunday Edition Newspaper:Y
First Newspaper Name:Pocono Record
First Advertisement Start Date:2021-10-17
Second Newspaper Name:Pocono Record
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-10-24
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:2021-10-12
Pro.Org. Ad to Date:2021-10-26
Job Search Website from Date:2021-10-11
Job Search Website to Date:2021-10-25
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:
Local Ethnic Newspaper to Date:
Radio/TV Ad from Date:2021-10-26
Radio/TV Ad to Date:2021-10-26
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:DRUG REGULATORY AFFAIRS
Year of Compelted Education:2016
Foreign Worker Istitution of Eduation:LONG ISLAND UNIVERSITY
Foreign Worker Education Instution Address Line 1:1 UNIVERSITY DRIVE
Foreign Worker Education Institution Address Line 2:
