Regulatory Affairs Specialist

2 weeks ago


Fremont, California, United States Yoh Full time
Regulatory Affairs Associate I

Yoh, a leading staffing company, is seeking a highly skilled Regulatory Affairs Associate I 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 standards.

Key Responsibilities:
  • Assist in preparing responses to global information requests and related maintenance documentation 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.
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/Experience:
  • 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.
What We Offer:
  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & weekly ePayroll
  • Employee Discount Programs
  • Referral Bonus Programs

Yoh is an Equal Opportunity Employer and welcomes all qualified applicants. We are committed to providing a diverse and inclusive work environment.



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