Regulatory Affairs Specialist

3 weeks ago


Fremont, California, United States Yoh Full time

Job Summary:

Yoh is seeking a highly skilled Regulatory Affairs/Quality Associate to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and cGMP requirements.

Key Responsibilities:

  • Help determine regulatory strategies for manufacturing changes and regulatory activities.
  • 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).
  • Provide support to Regulatory management as needed.
  • 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.

Requirements:

  • 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).

What We Offer:

  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & weekly ePayroll
  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


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