Regulatory Affairs Associate

Regulatory Affairs Associate located in Fremont, CA.
Details for the position are as follows:

Pay Rate: $34.26/hr. Job Description/Responsibilities: Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.)
within a defined time schedule. Help determine regulatory strategies for manufacturing changes and regulatory activities. Aid in preparing Lifecycle Management like Annual Reports (Product, DMF). Coordinate and track workflows for regulatory submissions. Ensure regulatory submissions meet global standards. Participate in meetings and interact with project team members and sub-teams. Assist with and eventually lead licensing activities and required updates (Establishment Registration, California State License, State licensing). Support reporting requirements under the CARES Act. Provide support to Regulatory management as needed.
Qualifications: Bachelor's degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master's Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. MS Office Suite (Outlook, Word, Excel, PowerPoint, etc.
). Regulatory Affairs Chemistry Document Management/Documentation cGMP