Agent/ Attorney Address Line 1:2400 N. Glenville Dr., Building A
Agent/ Attorney Address Line 2:Suite 100
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@balglobal.com
Position Info
Prevailing Wage Track Number:P10020230771791
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
Prevailing Wage Skill Level:Level II
Prevailing Wage:103418
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-01-22
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:111944
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:One Amgen Center Drive
Worksite Address Line 2:
Worksite City :Thousand Oaks
Worksite State:CALIFORNIA
Worksite Postal Code:91320
Job Title:Regulatory Affairs Manager
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:See H.14
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :24
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:5
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:24
Accept Alternate Job Title:See H.14
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:MASTERS DEGREE IN ENVIRONMENTAL, SAFETY AND HEALTH MANAGEMENT OR RELATED FIELD AND 2 YEARS OF EXPERIENCE INVOLVING THE FOLLOWING MAINTAINING REGULATORY COMPLIANCE BY ASSESSMENT OF CHANGE CONTROLS OPENED TO CAPTURE CHANGES PERFORMED IN MANUFACTURING OF PRODUCTS; INFORMING MULTIDISCIPLINARY PRODUCT TEAMS ON ADEQUATE SCIENTIFIC BASED STRATEGIES TO SUPPORT REGULATORY FILINGS; MAINTAINING GLOBAL REGULATORY GUIDANCE UPDATES TO INFORM MULTIDISCIPLINARY TEAMS AND HELP IN DEVELOPING REGULATORY FILING STRATEGIES; AND EMPLOYING CHEMISTRY MANUFACTURING AND CONTROLS CMC AND GOOD MANUFACTURING PRACTICE GMP REGULATIONS TO SUPPORT SITE ACTIVITIES AND ADHERENCE TO REGULATORY COMPLIANCE FOR PHARMACEUTICAL PRODUCTS.br ORbr BACHELORS DEGREE IN ENVIRONMENTAL, SAFETY AND HEALTH MANAGEMENT OR RELATED FIELD AND 5 YEARS OF PROGRESSIVE EXPERIENCE INVOLVING THE FOLLOWING MAINTAINING REGULATORY COMPLIANCE BY ASSESSMENT OF CHANGE CONTROLS OPENED TO CAPTURE CHANGES PERFORMED IN MANUFACTURING OF PRODUCTS; INFORMING MULTIDISCIPLINARY PRODUCT TEAMS ON ADEQUATE SCIENTIFIC BASED STRATEGIES TO SUPPORT REGULATORY FILINGS; MAINTAINING GLOBAL REGULATORY GUIDANCE UPDATES TO INFORM MULTIDISCIPLINARY TEAMS AND HELP IN DEVELOPING REGULATORY FILING STRATEGIES; AND EMPLOYING CHEMISTRY MANUFACTURING AND CONTROLS CMC AND GOOD MANUFACTURING PRACTICE GMP REGULATIONS TO SUPPORT SITE ACTIVITIES AND ADHERENCE TO REGULATORY COMPLIANCE FOR PHARMACEUTICAL PRODUCTS. Any suitable combination of experience of education, training, or experience is acceptable.
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:2021-03-18
Job Oder End Date:2021-04-20
Sunday Edition Newspaper:Y
First Newspaper Name:Los Angeles Daily News
First Advertisement Start Date:2021-04-04
Second Newspaper Name:Los Angeles Daily News
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-04-11
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:2021-03-30
Pro.Org. Ad to Date:2021-04-06
Job Search Website from Date:2021-03-30
Job Search Website to Date:2021-04-06
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:2021-04-07
Local Ethnic Newspaper to Date:2021-04-07
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:Master's
Foreign Worker Education Other:
Foreign Worker Major:ENVIRONMENTAL, SAFETY, AND HEALTH MANAGEMENT
Year of Compelted Education:2015
Foreign Worker Istitution of Eduation:THE UNIVERSITY OF FINDLAY
Foreign Worker Education Instution Address Line 1:1000 N MAIN ST.
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:FINDLAY
Foreign Worker Educatution Institution State:OH
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:45840
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
Foreign Worker Alternate Education and Experience :N
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:Laura Bloniarz
Preparer Title:Senior Associte
Preparer Email :labloniarz@balglobal.com
Employer Information Declaration Name:Jen Cummings
