Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate Location: Fremont, CA Duration: 20 Months Shift Timing: 1st Shift: Mon-Fri, 8:00AM-5:00PM DUTIES: 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.
SKILLS: PC literacy is required. Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project), Document Management Systems and Internet resources, is expected. General knowledge and application of global regulations and cGMP requirements are necessary. Must be able to work independently and with appropriate supervision. Excellent organizational, interpersonal, and communication skills (oral and written) are required.
EDUCATION: A 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.