Regulatory Affairs Associate Regulatory Affairs Fremont, CA, US Pay Rate Low: 34.00 | Pay Rate High: 36.00 + Added - 07/10/2024 Apply for Job **_Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Regulatory Affairs Associate to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!_** **Pay:** $30-36/hr **Shift:** Monday-Friday 8:00am-5:00pm **Location:** Fremont, CA **Key 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. **Education/Experience:** + 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. + Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project), Document Management Systems and Internet resources. + General knowledge and application of global regulations and cGMP requirements are necessary. \#INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.