Administrative Assistant -Supports the Regulatory Affairs team
Sunnyvale, CA - onsite at least 3 days a week (negotiable which days)
Primary Function of Position- Looking for someone to start ASAP
- More of an Administrative role
- Heavily support regulatory aspects of the business
- Don't need to be knowledgeable of regulatory strategy, but understandwhat it'slike to work in regulatory environment
- Looking for someone who is efficient
- Proficient in MS Office Products
- Possibility for extension and conversion
- Interview Process: 2 screening interviews 30 minutes each on Zoom, then bring them onsite
- Shortlisting on Wednesday
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