Regulatory Affairs Specialist

1 day ago

Fremont, California, United States Yoh, A Day & Zimmermann Company Full time
Job Title: Regulatory Affairs Associate I

Yoh, a Day & Zimmermann company, is seeking a highly skilled Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will play a critical role in ensuring compliance with global regulations and cGMP requirements.

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.
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, a Day & Zimmermann company, is an Equal Opportunity Employer. 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.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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