PREMIER RESEARCH INTERNATIONAL LLC

Senior Associate of Regulatory Affairs

A-22228-06703 H-1B 2023 Certified

Salary

$116,355

Visa Type

H-1B

Job Title

Senior Associate of Regulatory Affairs

Employee's Citizenship

INDIA

Graduate School

NORTHEASTERN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22228-06703

Case Status Certified

Received Date 2022-10-11

Decision Date 2023-08-24

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 PREMIER RESEARCH INTERNATIONAL LLC

Employer Address_Line 1 3800 PARAMOUNT PARKWAY

Employer Address_Line 2 SUITE 400

Employer City MORRISVILLE

State -

Employer State/ Province NORTH CAROLINA

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 27560

Employer Phone No. 1-984-569-6752

Employer Phone Extent No. -

Total Number of Employees 776

Employer Year of Commenced 2008

NAICS Code 5417

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Christopher Arceneaux

Employer Contact Address Line1 3800 Paramount Parkway

Employer Contact Address Line2 Suite 400

Employer Contact City Morrisville

Employer Contact State/ Provice NORTH CAROLINA NC

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 27560

Employer Contact Phone 9845696752

Employer Contact Email Christopher.Arceneaux@premier-research.com

Attorney

11 fields

Agent/ Attorney Name Christian O Herrmann

Agent/ Attorney Firm Name Ogletree, Deakins, Nash, Smoak Stewart P.C.

Agent/ Attorney Phone 8642408214

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 300 North Main Street

Agent/ Attorney Address Line 2 Suite 500

Agent/ Attorney City Greenville

Agent/ Attorney State/ Province SOUTH CAROLINA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 29601

Agent/ Attorney Email christian.herrmann@ogletree.com

Position Info

89 fields

Prevailing Wage Track Number P10022007814974

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Compliance Officers

Prevailing Wage Skill Level Level IV

Prevailing Wage 116355

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-06-29

Prevailing Wage Expiration Date 2022-09-27

Wage Offer From 116355

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 8000 Jarvis Avenue

Worksite Address Line 2 Suite 100

Worksite City Newark

Worksite State CALIFORNIA

Worksite Postal Code 94560

Job Title Senior Associate of Regulatory Affairs

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Regulatory Affairs, Biomedical Sciences, or a closely related field of study.

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study Y

Accept Alternate Major Regulatory Affairs, Biomedical Sciences, or a closely related field of study

Alternate Combination of Education/ Experience Y

Required Alternate Level of Education Master's

Other Alternate Level of Education -

Acceptable Years of Experience 2

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 60

Accept Alternate Job Title See H.14.

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills At least a Bachelors degree in Regulatory Affairs, Biomedical Sciences, or a closely related field of study and five 5 years of experience in the pharmaceutical industry as a Senior Regulatory Affairs Specialist, Regulatory Affairs Associate II, Associate, Regulatory Affairs, Regulatory Affairs Coordinator, Regulatory Affairs Associate, or closely related occupation. Employer will also accept a Masters degree in Regulatory Affairs, Biomedical Sciences, or a closely related field of study and two 2 years of experience in the pharmaceutical industry as a Senior Regulatory Affairs Specialist, Regulatory Affairs Associate II, Associate, Regulatory Affairs, Regulatory Affairs Coordinator, Regulatory Affairs Associate, or closely related occupation. Also requires education or experience in the followingbr br Two years of experience in Regulatory Affairs;br US Pharmaceutical and US Food and Drug Administration FDA Regulations;br Understanding of international regulations, processes and issues in drugbiologics development; andbr Knowledge of GCP Good Clinical Practice, ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, FDA, and EMA European Medicines Agency.

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 2022-08-09

Job Oder End Date 2022-09-08

Sunday Edition Newspaper Y

First Newspaper Name The Mercury News

First Advertisement Start Date 2022-07-03

Second Newspaper Name The Jose Mercury News

Second Advertisement Type Newspaper

Second Ad Start Date 2022-07-10

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 -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-06-29

Job Search Website to Date 2022-07-13

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 2022-07-08

Local Ethnic Newspaper to Date 2022-07-14

Radio/TV Ad from Date 2022-07-05

Radio/TV Ad to Date 2022-07-06

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

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major REGULATORY AFFAIRS

Year of Compelted Education 2011

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 N/A

Foreign Worker Alternate Education and Experience Y

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 Christian O Herrmann

Preparer Title Attorney

Preparer Email christian.herrmann@ogletree.com

Employer Information Declaration Name Shirley Mziray

Employer Declaration Title HR Coordinator Immigration Specialist