KARYOPHARM THERAPEUTICS
Senior VP, Regulatory Affairs
A-23040-99744
TN
2023
Withdrawn
Salary
$180,294
Visa Type
TN
Job Title
Senior VP, Regulatory Affairs
Employee's Citizenship
UNITED STATES OF AMERICA
Graduate School
NORTHEASTERN UNIVERSITY
Case info
9 fields
Data Publish Year
2023
Case Number
A-23040-99744
Case Status
Withdrawn
Received Date
2023-02-21
Decision Date
2023-03-02
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
KARYOPHARM THERAPEUTICS
Employer Address_Line 1
85 WELLS AVE
Employer Address_Line 2
FL 2
Employer City
NEWTON
State
-
Employer State/ Province
MASSACHUSETTS
Employer Country
UNITED STATES OF AMERICA
Employer Postal Code
2459
Employer Phone No.
6176580600
Employer Phone Extent No.
-
Total Number of Employees
397
Employer Year of Commenced
2008
NAICS Code
3254
Foreign Worker Ownership & Interest
N
HR Info
9 fields
Employer Contact Name
Loaiza-Gonzalez Emerson
Employer Contact Address Line1
85 WELLS AVE
Employer Contact Address Line2
FL 2
Employer Contact City
NEWTON
Employer Contact State/ Provice
MASSACHUSETTS
Employer Contact Country
UNITED STATES OF AMERICA
Employer Contact Post Code
2459
Employer Contact Phone
617-658-0600
Employer Contact Email
e.loaizagonzalez@karyopharm.com
Attorney
11 fields
Agent/ Attorney Name
Greg D Perl
Agent/ Attorney Firm Name
Perl Law PC
Agent/ Attorney Phone
6464700452
Agent/ Attorney Phone Ext.
-
Agent/ Attorney Address Line 1
110 E 59th St
Agent/ Attorney Address Line 2
Fl 23
Agent/ Attorney City
New York
Agent/ Attorney State/ Province
NEW YORK
Agent/ Attorney Country
UNITED STATES OF AMERICA
Agent/ Attorney Postal Code
10022
Agent/ Attorney Email
greg@perllaw.com
Position Info
89 fields
Prevailing Wage Track Number
P10022076988265
Prevailing Wage SOC Code
11-9199
Prevailing Wage SOC Title
Managers, All Other
Prevailing Wage Skill Level
Level IV
Prevailing Wage
180294
Prevailing Wage Unit of Pay
Year
Prevailing Wage Source
OES
Prevailing Wage Other Source
-
Prevailing Wage Determination Date
2022-09-21
Prevailing Wage Expiration Date
2023-06-30
Wage Offer From
350000
Wage Offer To
-
Wage Offer Unit of Pay
Year
Workstie Address Line 1
85 Wells Ave
Worksite Address Line 2
Fl 2
Worksite City
Newton
Worksite State
MASSACHUSETTS
Worksite Postal Code
2459
Job Title
Senior VP, Regulatory Affairs
Minimum Education
Bachelor's
Other Degree/ Diploma
-
Major Field of Study
Life Science or Regulatory Science
Required Training
N
Required Training Month
-
Required Field of Training
-
Required Experience
Y
Required Expreience Months
72
Accept Alternate Field of Study
N
Accept Alternate Major
-
Alternate Combination of Education/ Experience
Y
Required Alternate Level of Education
Master's
Other Alternate Level of Education
-
Acceptable Years of Experience
4
Accept Foreign Educationa
Y
Acceptable Alternate Occupation
N
Acceptable Alternate Occupation Month
-
Accept Alternate Job Title
-
Normal Requirements of Job Opportunity
Y
Required Foreign Language
N
Specific Skills
At least 4 years of experience managing multiple regulatory affairs subfunctions including Regulatory Labeling; Advertising and Promotion Compliance; Regulatory Intelligence, Science and Policy; Chemistry and Manufacturing Controls; Regional Regulatory Affairs; and Regulatory Operations; At least 4 years of experience working directly with the FDA and EMA as the Regulatory Lead of new drug applications, supplemental new drug applications and marketing authorization applications; At least 4 years of experience in regulatory affairs within the early and latephase of drug andor biologics product development; and At least 4 years of experience preparing and submitting regulatory documents including IND, CTA, NDA, and MAA.br br br Employer will accept Bachelors degree or foreign academic equivalent in Life or Regulatory Sciences or related and six 6 years of experience in a regulatory affairs role in the pharmaceutical or biologics industry.br br Employer will also accept a Masters degree or foreign academic equivalent in Life or Regulatory Sciences or related and four 4 years of experience in a regulatory affairs role in the pharmaceutical or biologics industry.br br Employer will accept any suitable combination of education, training and 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
2022-11-19
Job Oder End Date
2022-12-23
Sunday Edition Newspaper
Y
First Newspaper Name
Boston Sunday Globe
First Advertisement Start Date
2022-11-27
Second Newspaper Name
Boston Sunday Globe
Second Advertisement Type
Newspaper
Second Ad Start Date
2022-12-04
Job Fair From Date
-
Job Fair to Date
-
On Campus Recruiting from Date
-
On Campus Recruiting to Date
-
Employer Website from Date
2022-11-18
Employer Website to Date
2022-12-03
Pro. Org. Ad from Date
-
Pro.Org. Ad to Date
-
Job Search Website from Date
2022-11-18
Job Search Website to Date
2022-12-03
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
2022-11-30
Local Ethnic Newspaper to Date
2022-11-30
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
UNITED STATES OF AMERICA
Foreign Worker Birth Country
HONG KONG
Class of Admission
TN
Employee Info
24 fields
Foreign Worker Education
Master's
Foreign Worker Education Other
-
Foreign Worker Major
CLINICAL RESEARCH IN DRUGS, BIOLOGICS, AND MEDICAL DEVICES REGULATORY AFFAIRS
Year of Compelted Education
2021
Foreign Worker Istitution of Eduation
NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1
360 HUNTINGTON AVE
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
Y
Foreign Worker Alternate Education and Experience
Y
Foreign Worker Alternate Occupation Experience
N/A
Foreign Worker Experience with Employer
N
Foreign Worker Employer Pay for Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Greg D Perl
Preparer Title
Attorney
Preparer Email
greg@perllaw.com
Employer Information Declaration Name
Emerson LoaizaGonzalez
Employer Declaration Title
Principal, HR Operations Specialist