Regulatory Affairs Associate I

Company: Joul--
Location: Fremont
Posted on: November 20, 2024

Job Description:

Job Title: Regulatory Associate I

Find out more about this role by reading the information below, then apply to be considered.

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.

Keywords: Joul--, Sunnyvale , Regulatory Affairs Associate I, Other , Fremont, California