Agent/ Attorney State/ Province:DISTRICT OF COLUMBIA
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:20004
Agent/ Attorney Email:JBurritt@seyfarth.com
Position Info
Prevailing Wage Track Number:P10021013010230
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level III
Prevailing Wage:78437
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-05-24
Prevailing Wage Expiration Date :2021-08-22
Wage Offer From:93267
Wage Offer To:103267
Wage Offer Unit of Pay:Year
Workstie Address Line 1:Three Corporate Drive
Worksite Address Line 2:
Worksite City :Lake Zurich
Worksite State:ILLINOIS
Worksite Postal Code:60047
Job Title:Senior Regulatory Specialist
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:Chemistry, Biology or Microbiology
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:Please see H.11.
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Bachelors degree or foreign education equivalent in Chemistry, Biology or Microbiology plus four 4 years of experience in pharmaceutical Regulatory Affairs, including preparation and filing of complete ANDAs, supplements, amendments and annual reports to the Food and Drug Administration. Specific skillsother requirements Must also possess the following 1 Demonstrated expertise DE developing regulatory strategies for resolving complex issues related to new pharmaceutical product development and lifecycle management; 2 DE determining and analyzing regulatory requirements for submissions and change controls for pharmaceutical products to ensure compliance with the CFR, FDAICH guidelines and cGMPs; and 3 DE writing sections of regulatory submissions, responses to agency requests, and annual reports.
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:2021-07-23
Job Oder End Date:2021-08-25
Sunday Edition Newspaper:Y
First Newspaper Name:Chicago Tribune
First Advertisement Start Date:2021-08-15
Second Newspaper Name:Chicago Tribune
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-22
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:2021-08-02
Job Search Website to Date:2021-08-16
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:2021-08-04
Local Ethnic Newspaper to Date:2021-08-04
Radio/TV Ad from Date:2021-08-19
Radio/TV Ad to Date:2021-08-19
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 :L-1
Employee Info
Foreign Worker Education:Bachelor's
Foreign Worker Education Other:
Foreign Worker Major:MICROBIOLOGY
Year of Compelted Education:2002
Foreign Worker Istitution of Eduation:GURUKULA KANGRI VISHWAVIDYALAYA, HARIDWAR
Foreign Worker Education Instution Address Line 1:GURUKUL KANGRI VISHWAVIDYALAYA
Foreign Worker Education Institution Address Line 2:JAGJEETPUR
