Regulatory Affairs Associate I Job at Planet Group, Fremont, CA

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  • Planet Group
  • Fremont, CA

Job Description

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.

Pay Rate Range: $20-35/hr depending on experience

Job Tags

Contract work,

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