All Details of Green Card Application:
Explore Trends, Employment Opportunities, and Insights
Case Number: A-21203-21255
Fiscal year: 2022
Fiscal Year
2022
Case Number
A-21203-21255
Case Status
Certified-Expired
Received Date
2021-08-17
Decision Date
2022-01-28
Refile
N
Original File Date
2022-01-01 10:50:28
Previous SWA Case Number State
Schedule A Sheepherder
N
Employer Name
AMGEN INC.
Employer Name Slug
amgen-inc
Employer Address 1
ONE AMGEN CENTER DRIVE
Employer Address 2
Employer City
THOUSAND OAKS
Employer City Slug
thousand-oaks
Employer State
CALIFORNIA
Employer State Slug
california
Employer Country
UNITED STATES OF AMERICA
Employer Postal Code
91320
Employer Phone
805-447-1000
Employer Number of Employees
12973
Employer Year Commenced Business
1980
NAICS Code
54171
FW Ownership Interest
N
Employer Contact Name
Jenny Cummings
Employer Contact Address 1
2202 N. Westshore Blvd.
Employer Contact Address 2
Employer Contact City
Tampa
Employer Contact State/Province
FLORIDA
Employer Contact Country
UNITED STATES OF AMERICA
Employer Contact Postal Code
33607
Employer Contact Phone
813-392-0428
Employer Contact Email
jen01@amgen.com
Agent Attorney Name
Laura Bloniarz
Agent Attorney Firm Name
Berry Appleman Leiden LLP
Agent Attorney Phone
469-290-9687
Agent Attorney Address 1
2400 N. Glenville Dr., Building A
Agent Attorney Address 2
Agent Attorney City
Richardson
Agent Attorney State/Province
TEXAS
Agent Attorney Country
UNITED STATES OF AMERICA
Agent Attorney Postal Code
75082
Agent Attorney Email
labloniarz@bal.com
PW Track Number
P10021012007002
PW SOC Code
11-9199
PW SOC Title
Regulatory Affairs Managers
PW Skill Level
Level IV
PW Wage
164694.00
PW Unit of Pay
Year
PW Wage Source
OES
PW Determination Date
2021-05-20
PW Expiration Date
2021-08-18
Wage Offer From
201883.50
Wage Offer To
0.00
Average Salary
201883.50
Wage Unit of Pay
Year
Worksite Address 1
360 Binney Street
Worksite Address 2
Worksite City
Cambridge
Worksite City Slug
cambridge
Worksite State
MASSACHUSETTS
Worksite Postal Code
2141
Job Title
Director, Global Regulatory Affairs
Job Title Slug
director-global-regulatory-affairs
Minimum Education
Master's
Major Field of Study
See H.14
Required Training
N
Required Experience
Y
Required Experience Months
72
Accept Alternative Field of Study
N
Accept Alternative Major Field of Study
Accept Alternative Combination
N
Accept Alternative Combination Education
Accept Alternative Combination Education Years
Accept Foreign Education
Y
Accept Alternative Occupation
Y
Accept Alternative Occupation Months
72
Accept Alternative Job Title
See H.14
Job Opportunity Requirements Normal
N
Foreign Language Required
N
Specific Skills
MASTERS DEGREE IN DRUG REGULATORY AFFAIRS OR A RELATED FIELD AND 6 YEARS OF PROGRESSIVE EXPERIENCE IN THE FOLLOWING DEVELOPING REGULATORY STRATEGIES FOR NOVEL GLOBAL ONCOLOGY PRODUCTS INCLUDING SUBMISSION AND APPROVAL OF MARKETING APPLICATIONS; REPRESENTING GLOBAL REGULATORY AFFAIRS ON THE PRODUCT STRATEGY TEAM AND OTHER KEY COMMERCIALIZATION GOVERNANCE BODIES; DEVELOPING GLOBAL REGULATORY STRATEGIC PLANS THROUGH INTEGRATION OF REGIONAL REGULATORY STRATEGIES; LEADING INTERACTIONS AND NEGOTIATIONS WITH GLOBAL REGULATORY AGENCIES; PROVIDING GUIDANCE ON REGULATORY MECHANISMS TO OPTIMIZE ONCOLOGY PRODUCT DEVELOPMENT AND INCORPORATE THESE MECHANISMS INTO THEbr GLOBAL REGULATORY STRATEGY. SUCH MECHANISMS INCLUDE LEVERAGING EXPEDITED PATHWAYS TO DRUG APPROVAL FAST TRACK DESIGNATION,br BREAKTHROUGH THERAPY DESIGNATION, PRIORITY REVIEW, ACCELERATED APPROVAL, ORPHAN DRUG DESIGNATION, AND PEDIATRIC PLANS; AND OVERSEEING THE PLANNING AND IMPLEMENTATION OF GLOBAL REGULATORY FILINGS SUCH AS INVESTIGATIONAL NEW DRUG APPLICATIONS, CLINICAL TRIALbr APPLICATIONS, MARKETING APPLICATIONS, LABEL EXTENSIONS, AND CHEMISTRY MANUFACTURING AND CONTROLS CHANGES.br br Any suitable combination of education, training, or experience is acceptable.
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
2021-06-04
SWA Job Order End Date
2021-07-13
Sunday Edition Newspaper
Y
First Newspaper Name
The Boston Globe
First Advertisement Start Date
2021-06-20
Second Newspaper Ad Name
The Boston Globe
Second Advertisement Type
Newspaper
Second Ad Start Date
2021-06-27
Employer Website From Date
2022-01-01 10:50:28
Employer Website To Date
2022-01-01 10:50:28
Professional Organization Ad From Date
2021-06-15
Professional Organization Advertisement To Date
2021-06-22
Job Search Website From Date
2021-06-15
Job Search Website To Date
2021-06-22
Employee Referral Program From Date
2022-01-01 10:50:28
Employee Referral Program To Date
2022-01-01 10:50:28
Local Ethnic Paper From Date
2021-06-25
Local Ethnic Paper To Date
2021-06-25
Radio/TV Ad From Date
2022-01-01 10:50:28
Radio/TV Ad To Date
2022-01-01 10:50:28
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
DRUG REGULATORY AFFAIRS
Foreign Worker Years of Education Completed
2009
Foreign Worker Institution of Education
LONG ISLAND UNIVERSITY
Foreign Worker Education Institution Address 1
1 UNIVERSITY PLAZA
Foreign Worker Education Institution Address 2
Foreign Worker Education Institution City
BROOKLYN
Foreign Worker Education Institution State/Province
NY
Foreign Worker Education Institution Country
UNITED STATES OF AMERICA
Foreign Worker Education Institution Postal Code
11201
Foreign Worker Experience with Employer
N
Foreign Worker Employer Pays for Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Laura Bloniarz
Preparer Title
Sr. Associate Immigration Attorney
Preparer Email
labloniarz@bal.com
Employer Information Declaration Name
Jen Loretta Cummings Lu
Employer Information Declaration Title
HR Representative