Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:98121
Employer Contact Phone:206-285-3500
Employer Contact Email:lmollenholt@path.org
Attorney
Agent/ Attorney Name:Felicia L Gittleman
Agent/ Attorney Firm Name:Cowan Miller Lederman
Agent/ Attorney Phone:2068769751
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:1000 Second Avenue
Agent/ Attorney Address Line 2:Suite 1620
Agent/ Attorney City:Seattle
Agent/ Attorney State/ Province:WASHINGTON
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:98104
Agent/ Attorney Email:fgittleman@cmlseattle.com
Position Info
Prevailing Wage Track Number:P10021063120114
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
Prevailing Wage Skill Level:Level IV
Prevailing Wage:134618
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-10-04
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:136872
Wage Offer To:198578
Wage Offer Unit of Pay:Year
Workstie Address Line 1:2201 Westlake Ave
Worksite Address Line 2:Suite 200
Worksite City :Seattle
Worksite State:WASHINGTON
Worksite Postal Code:98121
Job Title:Regulatory Affairs Manager
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:Life Science, Health Science or a related field
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:Life Science, Health Science or a related field
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:60
Accept Alternate Job Title:Any occupation with the skills in H.14.
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:A Bachelors degree in Life Science, Health Science or a related field, or the foreign degree equivalent, plus five years of progressive, postbaccalaureate regulatory affairs experience relating to health products. The work experience must include five years of experience in the followingbr 1. Create and implement regulatory strategies for drug andor vaccine development, which ensure compliance with the guidelines and regulations of the national regulatory authorities responsible for oversight of drugs andor vaccines in the locations where the product will be manufactured, tested and licensed for sale;br 2. Plan and coordinate meetings and lead negotiations with national health authorities to seek agreement on the requirements necessary to secure government approval of new health products;br 3. Utilize knowledge of applicable regulatory requirements, procedures and policies to prepare regulatory documents including applications for clinical trial approvals, applications for marketing authorizations and requests for meetings, briefing documents to support meetings, minutes of meetings with national regulatory authorities for submission to national regulatory authorities responsible for the oversight of drugs andor vaccines; andbr 4. Provide project management and oversight to ensure that the submissions are filed according to the required timelines defined by the national regulatory authorities responsible for the oversight of drugs andor vaccines.br br Experience may be gained concurrently.
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:2021-09-22
Job Oder End Date:2021-10-25
Sunday Edition Newspaper:Y
First Newspaper Name:The Seattle Times
First Advertisement Start Date:2021-09-26
Second Newspaper Name:The Seattle Times
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-10-03
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:2021-09-22
Job Search Website to Date:2021-10-04
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:2021-09-29
Local Ethnic Newspaper to Date:2021-09-29
Radio/TV Ad from Date:2021-09-29
Radio/TV Ad to Date:2021-09-29
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:CANADA
Foreign Worker Birth Country:CANADA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Bachelor's
Foreign Worker Education Other:
Foreign Worker Major:HEALTH SCIENCES
Year of Compelted Education:2004
Foreign Worker Istitution of Eduation:UNIVERSITY OF WESTERN ONTARIO NOW WESTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:1151 RICHMOND STREET
Foreign Worker Education Institution Address Line 2:
