Job Title: Regulatory Associate I

Location: Fremont, CA

Hours/Schedule: Full-time

Compensation: $25-33/hr

Overview
Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements as well as development projects. You will be the primary contact and provide super-user technical support to team members and cross-functional stakeholders for various internal systems and software programs, as well as specialized regulatory software.  Provide support to the Global Regulatory Team as needed in pursuit of Company goals and objectives.

Responsibilities Follow all company policies and procedures. Follow and ensure compliance to quality system and cGMP programs. Assist regulatory bodies, consultants and government officials in support of product approvals, labels and labeling. Assist with research in assigned markets specific to regulatory processes, product classification, and product registration requirements. Assist in preparing product dossiers for regulatory submission to regulatory
Requirements  A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy. 1-3 years of relevant industry experience 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 wor Excellent organizational, interpersonal, and communication skills (oral and written) are required.
 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.