Regulatory Affairs Specialist

3 weeks ago


Fremont, California, United States eTeam Full time
Job Title: Regulatory Affairs Specialist

At eTeam, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for assisting in preparing responses to global information requests and related maintenance documentation. Your duties will include determining regulatory strategies for manufacturing changes and regulatory activities, preparing Lifecycle Management like Annual Reports, and coordinating and tracking workflows for regulatory submissions. You will also ensure that regulatory submissions meet global standards and participate in meetings and interact with project team members and sub-teams. Additionally, you will assist with and eventually lead licensing activities and required updates, and support reporting requirements under the CARES Act.

Key Responsibilities:
  • Assist in preparing responses to global information requests and related maintenance documentation.
  • Determine regulatory strategies for manufacturing changes and regulatory activities.
  • Prepare Lifecycle Management like Annual Reports.
  • 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.
  • Support reporting requirements under the CARES Act.

Requirements:
  • 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.


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