Agent/ Attorney Address Line 1:135 S LaSalle Street
Agent/ Attorney Address Line 2:Ste. 3425
Agent/ Attorney City:Chicago
Agent/ Attorney State/ Province:ILLINOIS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:60603
Agent/ Attorney Email:jhoskin@zulkiepartners.com
Position Info
Prevailing Wage Track Number:P10021013010376
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
Prevailing Wage Skill Level:Level II
Prevailing Wage:106413
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-06-30
Prevailing Wage Expiration Date :2021-09-28
Wage Offer From:107000
Wage Offer To:195800
Wage Offer Unit of Pay:Year
Workstie Address Line 1:650 E. Kendall Street
Worksite Address Line 2:
Worksite City :Cambridge
Worksite State:MASSACHUSETTS
Worksite Postal Code:2142
Job Title:Mgr, US/Intl Reg Strategist, Global Reg Affairs Strategy
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:PHARMACY OR RELATED FIELD
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:36
Accept Alternate Job Title:Reg Affairs Coordinator or rltd pstn
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:WILL ACCEPT ANY LEVEL OF EXPERIENCE IN THE FOLLOWING SKILLS DESIGN, ESTABLISH AND IMPLEMENT QSR SYSTEM QUALITY SYSTEM REGULATION INCLUDING CREATION OF SOP, DEVELOP WORKFLOW FOR APPROVAL PROCESSES AND REGULATORY DOCUMENTATION FOR MEDICAL DEVICE; ANALYZE REGULATORY GUIDANCES FDA TITLE 21 CFR PART 820,801, 812,807,814, DETERMINE CLASSIFICATION PART 860, GCP AND ICH, ISO 13485 GUIDELINES RELATED TO MEDICAL DEVICE DEVELOPMENT; EXTRACT PHARMACEUTICAL PRODUCTSCOMPETITORSPRESCRIPTION TRENDS DATA FROM ORG IMS DATABASE PHARMACEUTICAL MARKET DATABASE, EVALUATE HEALTHCARE INFORMATION USING TOOLS, DEVELOP AND IMPLEMENT STRATEGY AND BUSINESS DEVELOPMENT PLAN FOR PHARMACEUTICALS; ENGAGE INTERNAL AND EXTERNAL STAKEHOLDERS, MANAGE, REVIEW AND EVALUATE PROMOTIONAL MATERIALS FOR PHARMACEUTICALS PRODUCTS IN COMPLIANCE WITH GUIDELINES FROM THE CENTRAL DRUGS STANDARD CONTROL ORGANIZATION CDSCO, THE DRUGS AND COSMETICS ACT DCA, 1940 AND THE DRUGS AND COSMETICS RULES 1945. 1020 TRAVEL REQUIRED.
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:2021-08-24
Sunday Edition Newspaper:Y
First Newspaper Name:The Boston Globe
First Advertisement Start Date:2021-07-25
Second Newspaper Name:The Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-01
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-07-23
Employer Website to Date:2021-08-25
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-07-25
Job Search Website to Date:2021-08-23
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:2021-07-29
Local Ethnic Newspaper to Date:2021-07-29
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:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Bachelor's
Foreign Worker Education Other:
Foreign Worker Major:PHARMACY
Year of Compelted Education:2005
Foreign Worker Istitution of Eduation:HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY PATAN
Foreign Worker Education Instution Address Line 1:MOTIPURA, HIMATNAGAR, NH8
Foreign Worker Education Institution Address Line 2:
