Amicis Global Technologies
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
Amicis Global Technologies, Mountain View, California, us, 94039
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
Join to apply for the
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
role at
Amicis Global Technologies Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
role at
Amicis Global Technologies Get AI-powered advice on this job and more exclusive features. Title:
Regulatory Affairs Specialist / Admin
Location:
Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
Duration:
06 Months
Pay Rate: $35.00 - $40.00/Hour on W2
Roles And Responsibilities
Supports the Regulatory Affairs team to help them stay organized and complete tasks that allow the team to focus on more advanced responsibilities. Contacts company personnel at all organizational levels to gather information and prepare reports. Analyzes problems, determines approach, compiles and analyzes data, and prepares reports/recommendations. Must demonstrate excellent written and oral communication
skills. Work is generally of a critical or confidential nature.
Creating, populating, and updating project trackers
Compiling data and preparing reports
Generating, updating, and archiving regulatory documentation
Organizing meetings (including note taking and distribution of meeting minutes)
Assisting Regulatory Submissions team with ECO creation, Product Registration database entry, and other processes related to documentation release and archival.
Carrying out administrative tasks in a fast-paced environment with many deadlines at all levels of the organization.
Coordinating activities between departments and outside parties.
Reviewing and updating work instructions and procedures related to regulatory submissions.
Creation of POs and submission of invoice payments for the Regulatory Affairs department.
Required Skills And Experience
Excellent written and verbal communication skills.
Effective time management and organization skills.
Attention to detail and self-motivated
Ability to work with associates with varied skills and levels of experience.
Basic computer skills
Proficient in Microsoft Office (Outlook, word, excel, powerpoint, etc.)
Ability to follow through and complete assigned tasks.
Required Education and Training
High school diploma/Secondary Education or equivalent; vocational training with
additional five (5) years of on-the-job training/experience in a related field
OR
Bachelor's degree (or equivalent) plus four (4) years of experience
Preferred Skills And Experience
Project Management experience a plus
Experience working with FDA websites
#CareerBuilder #Monster #Dice #Indeed Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Legal Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Amicis Global Technologies by 2x Get notified about new Regulatory Affairs Specialist jobs in
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Sunnyvale, CA $119,900.00-$203,000.00 3 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Join to apply for the
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
role at
Amicis Global Technologies Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
role at
Amicis Global Technologies Get AI-powered advice on this job and more exclusive features. Title:
Regulatory Affairs Specialist / Admin
Location:
Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
Duration:
06 Months
Pay Rate: $35.00 - $40.00/Hour on W2
Roles And Responsibilities
Supports the Regulatory Affairs team to help them stay organized and complete tasks that allow the team to focus on more advanced responsibilities. Contacts company personnel at all organizational levels to gather information and prepare reports. Analyzes problems, determines approach, compiles and analyzes data, and prepares reports/recommendations. Must demonstrate excellent written and oral communication
skills. Work is generally of a critical or confidential nature.
Creating, populating, and updating project trackers
Compiling data and preparing reports
Generating, updating, and archiving regulatory documentation
Organizing meetings (including note taking and distribution of meeting minutes)
Assisting Regulatory Submissions team with ECO creation, Product Registration database entry, and other processes related to documentation release and archival.
Carrying out administrative tasks in a fast-paced environment with many deadlines at all levels of the organization.
Coordinating activities between departments and outside parties.
Reviewing and updating work instructions and procedures related to regulatory submissions.
Creation of POs and submission of invoice payments for the Regulatory Affairs department.
Required Skills And Experience
Excellent written and verbal communication skills.
Effective time management and organization skills.
Attention to detail and self-motivated
Ability to work with associates with varied skills and levels of experience.
Basic computer skills
Proficient in Microsoft Office (Outlook, word, excel, powerpoint, etc.)
Ability to follow through and complete assigned tasks.
Required Education and Training
High school diploma/Secondary Education or equivalent; vocational training with
additional five (5) years of on-the-job training/experience in a related field
OR
Bachelor's degree (or equivalent) plus four (4) years of experience
Preferred Skills And Experience
Project Management experience a plus
Experience working with FDA websites
#CareerBuilder #Monster #Dice #Indeed Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Legal Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Amicis Global Technologies by 2x Get notified about new Regulatory Affairs Specialist jobs in
Mountain View, CA . Union City, CA $100,000.00-$120,000.00 3 weeks ago Regulatory Affairs Specialist - (NMPA/CFDA)
Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
Santa Clara, CA $79,500.00-$138,700.00 2 days ago Regulatory Affairs Assoc II CMC - Small Molecules
Senior Regulatory Affairs Specialist - Vascular (on-site)
San Jose, CA $172,000.00-$234,000.00 2 days ago Milpitas, CA $115,000.00-$150,000.00 2 weeks ago Sunnyvale, CA $80,000.00-$140,000.00 1 week ago Union City, CA $130,000.00-$155,000.00 6 days ago Sunnyvale, CA $118,000.00-$172,000.00 2 weeks ago Menlo Park, CA $118,000.00-$172,000.00 2 weeks ago Senior Regulatory Affairs Specialist -Vascular (on-site)
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
San Francisco Bay Area $60.00-$63.00 2 weeks ago Regulatory Affairs Compliance Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 2 weeks ago Union City, CA $100,000.00-$120,000.00 3 weeks ago Sr Regulatory Affairs Specialist - Shockwave Medical
Senior Regulatory Affairs Specialist – Vascular (on-site)
Associate Director, Regulatory Affairs - Global Labeling
Foster City, CA $165,495.00-$235,620.00 3 days ago Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
Sunnyvale, CA $119,900.00-$203,000.00 3 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr